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Medtronic Recall Check

Medtronic Recalls Defibrillators Over Manufacturing Defect

Medtronic Recalls Defibrillators Over Manufacturing Defect

Medtronic Recalls Defibrillators Over Manufacturing Defect Posted 26 February 2018 | By Ana Mulero A defect in the manufacturing process of certain Medtronic cardiac defibrillators, including implantable models, prompted a US Food and Drug Administration (FDA) Class I recall on Monday. The Minneapolis-based device maker sent an urgent medical device recall notice to customers earlier this year after becoming aware of the manufacturing defect that called for corrective actions, such as offering supplemental device warranties for the affected models of two products the Medtronic Cardiac Resynchronization Therapy with Defibrillation (CRT-Ds) and the Implantable Cardiovert-Defibrillators (ICDs). A total of nine CRT-Ds and 12 ICD models were affected and included in the recall. FDA has now identified the recall as the most serious type because the identified defect may prevent the CRT-Ds and ICDS from delivering the life-saving,electrical shock therapies patients need. The defect causes an out of specification gas mixture inside the device and may prevent the device from delivering the electrical shock needed to pace a patients heartbeat or revive a patient in cardiac arrest, the agency said. The delay or inability to deliver a shock to a patient in cardiac arrest or pace a patients heart whose heartbeat is too slow could result in serious injury and/or death. As part of the corrective actions, Medtronic also directed care providers to consider replacing the affected ICDs which include Evera and Visia models with prophylactic devices. Spokesperson Tracy McNulty told Focus that the companys manufacturing processes have been updated to prevent the specific manufacturing sequence associated with this issue from occurring. McNulty also confirmed all physicians following the 48 Continue reading >>

Medtronic Minimed Infusion Sets

Medtronic Minimed Infusion Sets

URGENT MEDICAL DEVICE RECALL INFORMATION Because the safety of our customers is our top priority, we are voluntarily recalling specific lots of infusion sets used with Medtronic insulin pumps. Explanation of the Issue Medtronic has become aware of recent reports of potential over-delivery of insulin shortly after an infusion set change. Over-delivery of insulin can cause hypoglycemia and in extreme cases, death. Medtronic has received reports of hypoglycemia requiring medical intervention potentially related to this issue. Our investigation has shown this can be caused by fluid blocking the infusion set membrane during the priming/fill-tubing process. A membrane blocked by fluid most likely occurs if insulin, alcohol, or water is spilled on top of the insulin reservoir which then could prevent the infusion set from working properly. Infusion sets currently being shipped by Medtronic contain a new and enhanced membrane material that significantly reduces this risk. Actions Required by You Go to to determine if you have recalled infusion sets. You will be prompted to enter the REF and LOT numbers for all infusion sets in your possession. The website will then tell you which infusion sets are part of this recall and which are not. Your REF and LOT numbers are listed on the labels as shown in the examples below: If you have new and enhanced infusion sets that are not part of this recall, use only those sets starting with your next set change. As a reminder, we have Key Steps regarding the priming/fill-tubing process. If you only have recalled infusion sets right now, it is very important that you carefully follow the Key Steps. Return your recalled infusion sets within the next four weeks the pre-paid label that has been sent to you. Medtronic will replace the recalled infu Continue reading >>

Medtronic Minimed Insulin Pump Lawsuits

Medtronic Minimed Insulin Pump Lawsuits

On November 18, 2017, the FDA announced a Class 2 device recall for over 9.5 million Medtronic MimiMed Infusion sets. A Class II recall is an immediate threat level recall, and identifies products that might cause a temporary health problem. The recall covers the MiniMed Sure-T, Mio, Silhouette, and Quick-Set Infusion Sets manufactured prior to April 2017. Medtronic MiniMed infusion sets used with non-Medtronic pumps and those without tubing are not covered by this recall. The recalled devices have the potential to over-deliver insulin to patients with diabetes, which can lead to hypoglycemia. Symptoms include anxiety, confusion, cold sweats, trembling, fatigue, hunger, and irritability. In extreme cases, hypoglycemia can cause seizures, coma, and even death. The company began informing patients and doctors about the recall in September 2017, noting that patient reports linked certain lots of the infusion sets to problems that could result in over-delivery of insulin. They advised consumers to check the companys website for information on lot numbers to see if they were using a recalled one of the products. Patients who have suffered serious injuries because of this or other issues with Medtronic insulin pumps and infusion sets may be eligible to file lawsuits in an attempt to recover damages. Some lawsuits have already been filed against the company. Chaffin Luhana is actively investigating whether other patients were hurt. What is a Medtronic MiniMed Insulin Pump? Patients with type 1 diabetes produce little or none of the hormone insulin, which helps the body process glucose from fuel. Without insulin, the bodys cells cant draw energy from food. The glucose then builds up in the bloodstream, which can cause high blood pressure and lead to other health problems. Pati Continue reading >>

Urgent Recall - Medtronic Minimed Infusion Sets

Urgent Recall - Medtronic Minimed Infusion Sets

Medtronic, in consultation with the Therapeutic Goods Administrations (TGA), has issued a global recall of some infusion sets used with Medtronic insulin pumps. This recall was initiated following recent reports of the potential over-delivery of insulin shortly after an infusion set change. Over-delivery of insulin can cause hypoglycaemia. To determine if you have any recalled infusion sets go to The website will prompt you to enter the REF and LOT numbers for all of the infusion sets in your possession. You will then be told which of the infusion sets are included in the recall, and which are not. If you have any recalled infusion sets, please complete the online form. To ensure that your replacement request is processed, make sure you click the SUBMIT button once your form is complete. Once the online form is submitted, replacement box/es of infusion sets will be sent by Medtronic directly to your nominated delivery address, free of charge. Please cut-out and retain the barcodes on your recalled infusion set boxes. These should be placed in the reply-paid envelope that will be included in the delivery of the replacement infusion sets. Send this envelope back to Medtronic but do not return the recalled infusion sets. You can dispose of your recalled infusion sets once you have returned the barcode to Medtronic. The following link contains more information on the recall, including important safety information about avoiding potential insulin over-delivery: Please do not use any of the recalled infusion sets. If necessary, please make use of your diabetes self-management back-up plan as agreed with your health professional until Medtronic are able to replace your recalled products. Medtronic has advised that replacement infusion sets are made with new and enhanced materi Continue reading >>

Medtronic Issues Global Voluntary Recall Of Certain Pump Infusion Sets

Medtronic Issues Global Voluntary Recall Of Certain Pump Infusion Sets

By Jeemin Kwon and Adam Brown Recall applies to sets manufactured before April 2017; Medtronic is replacing old sets that have a risk of insulin over-delivery Medtronic is voluntarily recalling specific lots of pump infusion sets manufactured before April 2017 as a result of reports of over-delivery of insulin following an infusion set change – check if your sets are affected here (US) and here (outside the US). Medtronic will replace your sets at no cost if they are part of the recall. If your sets were manufactured after April 2017, they are likely not affected, but it is safest to use the sites above to look them up. What’s the problem? The recall concerns a part of the infusion set called the “vent membrane,” which is inside the cap that connects the top of the reservoir to the set tubing. Medtronic has determined that if insulin, alcohol, or water is spilled on top of the insulin reservoir during the priming/fill-tubing process, the “vent membrane” can get wet and prevent the set from functioning properly. This can lead to over-delivery of insulin. We imagine this might happen if someone had wet hands or was changing a set in wet conditions. Sets manufactured after April 2017 contain an improved membrane that addresses the issue. Is the risk high? No. Medtronic estimates fewer than one event occurs for every two million infusion sets. Based on data reported from June 2016-August 2017, the company identified 28 reports of hypoglycemia (low blood sugar) shortly following an infusion set change. These episodes involved “medical intervention,” meaning some were serious and some presumably required assistance from a third person. Though the overall rate of occurrence was low, the incidents were still meaningful. This recall is being issued for safety, si Continue reading >>

Medtronic Minimed Infusion Sets

Medtronic Minimed Infusion Sets

URGENT MEDICAL DEVICE RECALL INFORMATION Because the safety of our customers is our top priority, we are voluntarily recalling specific lots of infusion sets used with Medtronic insulin pumps. Explanation of the Issue Medtronic has become aware of recent reports of potential over-delivery of insulin shortly after an infusion set change. Over-delivery of insulin can cause hypoglycemia and in extreme cases, death. Medtronic has received reports of hypoglycemia requiring medical intervention potentially related to this issue. Our investigation has shown this can be caused by fluid blocking the infusion set membrane during the priming/fill-tubing process. A membrane blocked by fluid most likely occurs if insulin, alcohol, or water is spilled on top of the insulin reservoir which then could prevent the infusion set from working properly. Infusion sets currently being shipped by Medtronic contain a new and enhanced membrane material that significantly reduces this risk. Actions Required by You Go to to determine if you have recalled infusion sets. You will be prompted to enter the REF and LOT numbers for all infusion sets in your possession. The website will then tell you which infusion sets are part of this recall and which are not. Your REF and LOT numbers are listed on the labels as shown in the examples below: If you have new and enhanced infusion sets that are not part of this recall, use only those sets starting with your next set change. As a reminder, we have Key Steps regarding the priming/fill-tubing process. If you only have recalled infusion sets right now, it is very important that you carefully follow the Key Steps. Return your recalled infusion sets within the next four weeks the pre-paid label that has been sent to you. Medtronic will replace the recalled infu Continue reading >>

Medtronic Recalls Cardiac Resynchronization Therapy And Implantable Cardioverter Defibrillators Due To Manufacturing Error Preventing Electrical Shock Delivery

Medtronic Recalls Cardiac Resynchronization Therapy And Implantable Cardioverter Defibrillators Due To Manufacturing Error Preventing Electrical Shock Delivery

Medtronic Recalls Cardiac Resynchronization Therapy and Implantable Cardioverter Defibrillators Due to Manufacturing Error Preventing Electrical Shock Delivery The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product(s): Medtronic Cardiac Resynchronization Therapy with Defibrillation (CRT-Ds) and Implantable Cardiovert-Defibrillators (ICDs) Manufacturing Dates: July 13, 2013 to August 8, 2017 Devices Recalled in the U.S.: 48 units nationwide Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are devices that provide pacing for slow heart rhythms, and electrical shock or pacing to stop dangerously fast heart rhythms. ICDs and CRT-Ds are both implanted under the skin in the upper chest area with connecting insulated wires called "leads" that go into the heart. Patients need an ICD or CRT-D if their heartbeat is too slow (bradycardia), too fast (tachycardia), or needs coordination to treat heart failure. Medtronic is recalling certain ICDs and CRT-Ds due to a defect in the manufacturing process. This defect causes an out of specification gas mixture inside the device and may prevent the device from delivering the electrical shock needed to pace a patients heartbeat or revive a patient in cardiac arrest. The delay or inability to deliver a shock to a patient in cardiac arrest or pace a patients heart whose heartbeat is too slow could result in serious injury and/or death. Patients with an affected Medtronic ICD or CRT-D device Caregivers of patients with an affected Medtronic ICD or CRT-D device Health care providers treating patients with heart failure or heart rhythm problems using affected Medtronic ICD or CRT-D de Continue reading >>

Medtronic Minimed Infusion Sets

Medtronic Minimed Infusion Sets

URGENT MEDICAL DEVICE RECALL INFORMATION Because the safety of our customers is our top priority, we are voluntarily recalling specific lots of infusion sets used with Medtronic insulin pumps. Explanation of the Issue Medtronic has become aware of recent reports of potential over-delivery of insulin shortly after an infusion set change. Over-delivery of insulin can cause hypoglycemia and in extreme cases, death. Medtronic has received reports of hypoglycemia requiring medical intervention potentially related to this issue. Our investigation has shown this can be caused by fluid blocking the infusion set membrane during the priming/fill-tubing process. A membrane blocked by fluid most likely occurs if insulin, alcohol, or water is spilled on top of the insulin reservoir which then could prevent the infusion set from working properly. Infusion sets currently being shipped by Medtronic contain a new and enhanced membrane material that significantly reduces this risk. Actions Required by You Go to to determine if you have recalled infusion sets. You will be prompted to enter the REF and LOT numbers for all infusion sets in your possession. The website will then tell you which infusion sets are part of this recall and which are not. Your REF and LOT numbers are listed on the labels as shown in the examples below: If you have new and enhanced infusion sets that are not part of this recall, use only those sets starting with your next set change. As a reminder, we have Key Steps regarding the priming/fill-tubing process. If you only have recalled infusion sets right now, it is very important that you carefully follow the Key Steps. Return your recalled infusion sets within the next four weeks the pre-paid label that has been sent to you. Medtronic will replace the recalled infu Continue reading >>

Recall Notice: Specific Lots Of Medtronic Minimed Infusion Sets

Recall Notice: Specific Lots Of Medtronic Minimed Infusion Sets

Diabetes Ireland are sharing the following information from Medtronic intended for Medtronic Pump users. Explanation of the Issue Medtronic has become aware of recent reports of potential over-delivery of insulin shortly after an infusion set change. Over-delivery of insulin can cause hypoglycemia and in extreme cases, death. Medtronic has received reports of hypoglycemia requiring medical intervention potentially related to this issue. Medtronic’s investigation has shown this can be caused by fluid blocking the infusion set membrane during the priming/fill-tubing process. A membrane blocked by fluid most likely occurs if insulin, alcohol, or water is spilled on top of the insulin reservoir which then could prevent the infusion set from working properly. Infusion sets currently being shipped by Medtronic contain a new and enhanced membrane material that significantly reduces this risk. Actions Required by You if using Medtronic devices A. Go to mmc.medtronic-diabetes.com/look to determine if you have recalled infusion sets. You will be prompted to enter the Ref and Lot number for all infusion set boxes in your possession. The website will then tell you which infusion sets are part of this recall and which are not. Your REF and LOT numbers are listed on the labels as shown in the below examples: If you have new and enhanced infusion sets that are not part of this recall, use only those new and improved sets starting with your next set change. If you only have recalled infusion sets, it is very important to carefully follow the instructions for use regarding the priming/fill-tubing process. Download the key steps 2c. Key Steps C. Discard recalled infusion sets when you have new and improved infusion sets and follow instructions on the website www.mmc.medtronic-diabetes. Continue reading >>

Press Release | Newsroom | Medtronic | Medtronic Voluntarily Recalls Specific Lots Of Paradigm Quick-set Infusion Sets In The United States

Press Release | Newsroom | Medtronic | Medtronic Voluntarily Recalls Specific Lots Of Paradigm Quick-set Infusion Sets In The United States

Medtronic Voluntarily Recalls Specific Lots of Paradigm Quick-Set Infusion Sets in the United States Company Is Providing Replacement Infusion Sets to Its Diabetes Customers at No Additional Charge MINNEAPOLIS July 10, 2009 Medtronic, Inc. (NYSE:MDT) said today that it has initiated a recall of specific lots of Quick-set infusion sets that are used with MiniMed Paradigm insulin pumps. An infusion set is a thin plastic tube used to deliver insulin from an insulin pump to a diabetes patient, and is typically replaced by the patient every three days. Affected infusion sets are reference numbers MMT-396, MMT-397, MMT-398 and MMT-399 with lot numbers starting with the number 8. Medtronic recently discovered that approximately two percent of Lot 8 Quick-set infusion sets (which represents approximately 60,000 infusion sets out of an estimated 3 million infusion sets currently with customers) may not work properly. The affected infusion sets may not allow the insulin pump to vent air pressure properly. This could potentially result in the device delivering too much or too little insulin and may lead to serious injury or death. Patients should discontinue using Lot 8 Quick-set infusion sets. The lot number (for example 8XXXXXX) is clearly marked on both the product box label, and on each individual infusion set package. Visit the Medtronic Diabetes website at www.medtronicdiabetes.com/lot8 to view the labels of Lot 8 Quick-set infusion sets. Customers are being asked to return any affected infusion sets to the company. Medtronic is providing customers with replacement Quick-set infusion sets at no additional charge. Lot 8 Quick-set infusion sets were distributed in the United States, and in limited quantities in a small number of countries outside of the United States. The lis Continue reading >>

Product Recall: Medtronic Minimed Infusion Sets

Product Recall: Medtronic Minimed Infusion Sets

Medtronic has announced a voluntary recall of their Medtronic MiniMed Infusion Sets. Why? There have been reports of over-delivery of insulin following infusion set changes. These occurrences of over-delivery of insulin can cause hypoglycemia, some cases being extreme and needing medical intervention. Medtronic states: Our investigation has shown this can be caused by fluid blocking the infusion set membrane during the priming/fill-tubing process. A membrane blocked by fluid most likely occurs if insulin, alcohol, or water is spilled on top of the insulin reservoir which then could prevent the infusion set from working properly. Infusion sets currently being shipped by Medtronic contain a new and enhanced membrane material that significantly reduces this risk. What You Can Do You can go to to see if you have recalled infusion sets. You’ll need to enter the REF and LOT numbers, which can be seen in this illustration, highlighted by the red boxes. Enter in the numbers for all of the infusion sets that you have to see if they are affected. Medtronic states not to use any of the infusion sets on the list. More Questions? Follow the process on the website at You can call Medtronic at 1.888.204.7616. You can also report an adverse event to the FDA’s MedWatch Adverse Event Reporting program: Report by telephone: 1.800.FDA.1088 Fax report: 1.800.FDA.0178 Continue reading >>

Medtronic Recalls Minimed Infusion Sets Over Blockage Issues

Medtronic Recalls Minimed Infusion Sets Over Blockage Issues

PORT WASHINGTON, N.Y., Sept. 15, 2017 /PRNewswire/ -- Parker Waichman LLP, a national law firm that has long been dedicated to protecting the rights of victims injured by allegedly defective drugs, is commenting on a global recall issued by Medtronic of specific lots of its MiniMed infusion sets, which are used with all models of Medtronic insulin pumps. Medtronic determined that the vent membrane in the recalled infusion sets may be susceptible to being blocked by fluid during the process of priming/fill-tubing. According to Medtronic, "This situation can lead to potential over-delivery of insulin shortly after an infusion set change, which may cause hypoglycemia" according to a September 11, 2017Medscape.com report. The currently manufactured infusion sets, which have been on the market since April 2017, include a design update of the component that Medtronic believes minimizes the risk for insulin over-delivery after an infusion set change. Medtronic also recommends that customers use only the infusion sets that are manufactured with the new and enhanced component. This component is called "the membrane" and should begin to be used with the next set change. Medtronic recommends that customers check online to see if they are in possession of recalled infusion sets. "Because this recall applies to all versions of infusion sets that are used with Medtronic insulin pumps, to publish a list of specific lot numbers would be unwieldy," said Pamela Reese, Medtronic senior manager for communications. "This is why we designed the lot look-up tool. When using this lot look-up, customers will be able to automatically process the exchange for new sets as well. "She noted that, "It is difficult to predict how many unused, recalled infusion sets are in customer hands that will need Continue reading >>

Medtronic Recalls Diabetes Infusion Sets For Overdose Risk

Medtronic Recalls Diabetes Infusion Sets For Overdose Risk

1 in 2 million sets susceptible to excess insulin delivery Company to replace sets at no cost; no financial details given Medtronic Plc is recalling a disposable device used with the company’s insulin pumps, after discovering that the part can trigger an excessive dose of the drug and put patients at risk of hypoglycemia. About one in every two million infusion sets manufactured before April may be associated with the complication, which occurs when a membrane that’s used to release pressure from inside the pump gets wet and blocks the vents, said Francine Kaufman, chief medical officer of Medtronic’s diabetes group. The risk of an excessive insulin dose is greatest right after the patient changes the infusion set, which is done every three days, she said. “Shortly after that change, the patient could experience insulin over-delivery,” she said in a telephone interview. There haven’t been any deaths associated with the flaw, Kaufman said. Most patients who had a problem were aware that their blood sugar had gone too low and were able to treat the condition. Others called an ambulance, went to the hospital or saw their doctors, she said. For patients with an infusion set that is in and working, nothing needs to be done, said Annette Bruls, president of Medtronic’s diabetes service and solutions business. Medtronic says it has fixed the problem and patients can use the devices that were made from April on. Medtronic, based in Dublin and run from Minneapolis, said the majority of the cost from the recall is expected to be incurred in the second quarter of the company’s fiscal year and will depend on the amount of unused sets that patients return. It isn’t expected to reduce earnings in the quarter or the full year, or impact revenue growth in the diabetes Continue reading >>

Medtronic Announces Voluntary Recall Of Diabetes Infusion Sets

Medtronic Announces Voluntary Recall Of Diabetes Infusion Sets

Announcement Medtronic plc (NYSE:MDT) announced today that it has started to inform patients worldwide of a voluntary recall of specific lots of infusion sets used with all models of Medtronic insulin pumps. The recall is related to a certain discontinued component in these infusion sets and does not include insulin pumps or glucose sensors. The company determined, through recent field reports from patients and root cause analysis, that a component, the vent membrane, in the recalled infusion sets may be susceptible to being blocked by fluid during the process of priming/fill-tubing. This situation can lead to potential over-delivery of insulin shortly after an infusion set change, which may cause hypoglycemia. Currently manufactured infusion sets, available to patients since April 2017, include a design update of this component which the company believes reduces the risk of insulin over-delivery after an infusion set change. The company will work with patients to ensure recalled infusion sets with the discontinued component are returned and replaced with new infusion sets containing the updated component at no cost. Medtronic has contacted the U.S. Food and Drug Administration (FDA), along with other regulatory bodies around the world, to share information related to this issue. Medtronic will continue working directly with government and regulatory authorities on this global voluntary recall. "Our priority is to work with our patients to mitigate risk to patient safety. While we have shipped a significant number of the new and enhanced sets since April, we are committed to replacing recalled infusion sets for all patients," said Francine Kaufman, M.D., chief medical officer of the Diabetes Group at Medtronic. "Our Medtronic Diabetes team will work as quickly as possib Continue reading >>

Medtronic Addresses Fda Recall For Strata Ii/strata Nsc And Stratamr Valves

Medtronic Addresses Fda Recall For Strata Ii/strata Nsc And Stratamr Valves

Medtronic Addresses FDA Recall for Strata II/Strata NSC and StrataMR valves Medtronic Addresses FDA Recall for Strata II/Strata NSC and StrataMR valves Tags: brain shunt , FDA recall , Strata II , Strata NSC , StrataMR Discussion on social media around the FDA notification regarding the Strata II/Strata NSC and StrataMR valves has led to a number of questions from patients. There are two actions currently being taken by the FDA and Medtronic to address issues with each of these products respectively. Medtronic has proactively implemented a Field Corrective Action (FCA) for its Strata II/Strata NSC valves. This type of FCA is referred to by the FDA as a Class II Recall. No actual shunt products are being recalled by Medtronic from the medical community. The FCA involves Medtronic updating their Instructions for Use (IFU) to make providers aware of a rare condition related to the Strata Valve that can lead to an inaccurate pressure level (PL) reading on the Strata Indicator Tool or StrataVarius system. The condition occurs only if a patient has been exposed to 3T MRI magnetic field or greater, and if biological debris is present to an extent that the valve magnet adjustment mechanism is impacted. This recall was initiated as a result of reported problems with the shunts in patients which occurred at an extremely low incident rate. Moving forward, new instructions will include this information in the packaging so medical professionals are aware as they monitor their patients after shunt surgery. Medtronic has also made a proactive decision to physically recall StrataMR valves still in stock at hospitals and medical facilities. This is to address an issue where the valve pressure level may be higher than anticipated. Medtronic is not recommending patients with the StrataMR Continue reading >>

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