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 Recall Specific Lot Numbers Of Minimed Infusion Sets
Medtronic have issued a recall to insulin pump users on specific lot numbers of MiniMed infusion sets, following reports of potential over-delivery of insulin, shortly after infusion set change. The over-delivery of insulin can be caused by fluid blocking the infusion set membrane during the priming/fill-tubing process. This most likely happens if insulin, alcohol or water is spilled on top of the insulin reservoir, which could stop the infusion set working properly. This could lead tohypos,and there have been reports of severe hypos, requiring medical assistance that could potentially be related to this issue. To resolve the issue, infusion sets currently being shipped by Medtronic contain a new membrane material that significantly reduces the risk of insulin over-delivery. Medtronic has issued the following actions for users of its insulin pumps: 1. Go to theMedtronic websiteto find out if you have the 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. 2. Medtronic recommends you do not use recalled infusion sets. 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. You will find key steps enclosed. 3. Discard recalled infusion sets when you have new and improved infusion sets and follow instructions on the website. Medtronic will replace the recalled infusion sets free of charge. Emma Elvin, Diabetes UK Clinical Advisor, said: “It’s important that anyone us Continue reading >>
Medtronic Announces Recall Of Diabetes Infusion Sets
The problem caused an overdelivery of insulin in some cases. A design update in April 2017 corrected the problem but some patients still have lots of defective infusion sets. Medtronic today announced that it is informing patients worldwide of a voluntary recall of certain lots of infusion sets used with its insulin pumps. According to a statement from the FDA, the recall is related to a discontinued component in these infusion sets and does not include the insulin pumps themselves or the glucose sensors, the critical device that reads a person’s blood sugar level in tissue fluid. The statement reads, in part, “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,” the statement continues. The FDA statement says Medtronic also contacted international regulatory agencies. The statement included a comment from Medtronic Diabetes Chief Medical Officer Francine Kaufman, MD, which reads in part: "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 Continue reading >>
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 >>
Medtronic Quick Set Infusion Sets | Injury Lawyers In New York
New York Medtronic Paradigm Quick-Set Lawyer Medical Device Liability Attorneys in New York Medtronic Paradigm Recall: Quick-Set Infusion Sets for MiniMed Insulin Pump The Medtronic Quick-Set Infusion sets are tubes used to deliver insulin with the MiniMed Paradigm pumps. The New York medical device lawyers at Rheingold Giuffra Ruffo & Plotkin LLP, help people who have been harmed by or lost loved ones due to the use of the defective Medtronic Quick-Sets. We are equipped to help you pursue monetary compensation for your medical bills, lost wages and other economic damages. At Rheingold Giuffra Ruffo & Plotkin LLP , we have been serving the legal needs of people throughout New York and across the nation for over 30 years. We handle a wide range of complex cases involving drug and medical device liability, including Medtronic Quick-Set lawsuits. The Dangers of Medtronic Paradigm Quick-Set Infusion Sets for MiniMed Insulin Pump Medtronic Inc. has recalled three million disposable infusion sets designed for their MiniMed Paradigm insulin pumps after discovering that some of them could deliver incorrect doses of insulin, potentially leading to injury or death. The Medtronic Paradigm recall involves one lot of Quick-set infusion sets, which are disposable plastic tubes used to infuse a diabetes patient from the Medtronic insulin pump. They are usually replaced after three days. Medtronic issued a press release on July 10 alerting users that approximately 2%, or about 60,000 units, from one lot of its infusion sets have a defect that could give too much insulin to the patient. The affected infusion sets have a lot number starting with "8" marked on the product box label and on each infusion set package, with the reference numbers MMT-396, MMT-397, MMT-398 and MMT-399. The def Continue reading >>
Medtronic Issues Wide-ranging Infusion Set Recall
9/11/2017 – 12:30 pm (EST) – This story has been updated. On September 11th, Medtronic issued a notice stating that the company is voluntarily recalling certain lots of infusion sets used with all models of its insulin pumps. The recall covers all lots of Medtronic infusion sets sent to customers before April 2017, except for its infusion sets with luer locks during that time period; this exception was first reported by Diabetes Mine and has been confirmed by Medtronic. The recall also may affect some lots of infusion sets shipped after April 2017. A Medtronic press release states that the recall involves a discontinued component that has since been replaced in infusion sets currently being sold by Medtronic. Medtronic undertook the recall after field reports suggested that a vent membrane in the infusion set could become blocked by fluid during the priming and filling process. This can increase the risk for overdelivery of insulin during pump use, which could in turn increase the risk of hypoglycemia in the pump user, according to the press release. Currently, Medtronic has only received reports of this happening in one out of every 2 million infusion sets in use, but that ratio very well might go up somewhat as news of the recall spreads. sponsor Medtronic reports that it has developed a membrane design update which the company believes will reduce the risk of overdelivery of insulin after a set change. This update was phased into infusion set lots shipped after April 2017. The company states it will replace infusion sets covered by the recall free of charge, and it discourages customers from using infusion sets from lots listed in the recall. In the FAQ section about the recall, the company states users should consider using multiple daily injections while waitin Continue reading >>
Medtronic Minimed Infusion Sets
Recall - potential for over-delivery of insulin and risk of hypoglycaemia Consumers and health professionals are advised that Medtronic Australasia, in consultation with the TGA, is recalling specific lots of Medtronic MiniMed infusion sets, including MiniMed Quick-set, MiniMed mio, MiniMed Silhouette and MiniMed Sure-T. Medtronic MiniMed infusion sets are used in conjunction with an insulin pump to deliver a continuous dose of insulin to help people with diabetes maintain normal blood glucose levels. There have been recent reports of potential over-delivery of insulin shortly after an infusion set change. Over-delivery of insulin can cause hypoglycaemia (low blood glucose level), which can lead to serious health complications. Subsequent investigations have found that this issue may 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 the top of the reservoir or inside the tubing connector, which could prevent the insulin set from working properly. Updated infusion sets contain a new and enhanced membrane material that significantly reduces this risk. People who have Medtronic MiniMed infusion sets are instructed to check the lot numbers either by visiting a Medtronic website or by calling Medtronic to see if their products are affected (see the 'Information for consumers' or 'Information for health professionals' sections below for further details). Information for consumers Medtronic Australasia has written to consumers who have Medtronic MiniMed infusion sets to provide further information about this issue, include details of the recall procedure and instructions regarding the priming/fill-tubing process (called 'Key Steps'). If you or s Continue reading >>
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 >>
Medtronic Recalls Specific Lots Of Diabetes Infusion Sets
(RTTNews) - Medtronic plc (MDT) announced a voluntary recall of specific lots of infusion sets used with all models of its insulin pumps related to a certain discontinued component in these infusion sets. The company noted that a component, the vent membrane, may be susceptible to being blocked by fluid during the process of priming/fill-tubing, which can lead to potential over-delivery of insulin shortly after an infusion set change, which may cause hypoglycemia and in extreme cases, death. Medtronic has received reports of hypoglycemia requiring medical intervention potentially related to this issue. Medtronic said will continue working directly with government and regulatory authorities on this global voluntary recall. Francine Kaufman, chief medical officer of the Diabetes Group at Medtronic, said, "Our Medtronic Diabetes team will work as quickly as possible to complete all exchanges to the new and enhanced set and fully support our customers throughout this process." Medtronic expects this recall of infusion sets not to impact Diabetes Group revenue growth in the second quarter or the full fiscal year. The company has provided the website to determine which REF and LOT numbers of the infusion sets are part of this recall. Continue reading >>
Medtronic Issues Voluntary Recall Of Certain Insulin Pump Infusion Sets
Medtronic is telling patients that certain lots of its infusion sets for its insulin pumps are being recalled as part of a voluntary effort. The problematic infusion sets, which patients can identify by checking REF and LOT numbers on the available site, have a vent membrane that may be more likely to get blocked, possibly leading to too-high levels of insulin being delivered. This could endanger the patient and potentially cause hypoglycemia. The vulnerable vent membrane was discontinued in April 2017, so infusion sets manufactured since then include an updated component and do not fall under this voluntary recall. Patients returning recalled sets will receive updated replacement sets for free. “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,” Francine Kaufman, MD, chief medical officer of the Diabetes Group at Medtronic, said in an FDA safety alert. “Our Medtronic Diabetes team will work as quickly as possible to complete all exchanges to the new and enhanced set and fully support our customers throughout this process.” Medtronic also stated that the voluntary recall is not expected to affect earnings per share guidance or Diabetes Group revenue growth for the current quarter—the second quarter of the company’s 2018 fiscal year—or the full fiscal year. The voluntary recall comes as patients are clamoring for Medtronic’s diabetes devices. On the company’s earnings call in August, CEO Omar Ishrak explained that high demand for the company’s sensors, using in its insulin pump systems, had exceeded supply. There is also strong patient appetite for the new Medtronic Mini Continue reading >>
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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 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 >>
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 >>
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 >>
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 >>
