diabetestalk.net

Medtronic Canada Recall

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 Recalls Certain Lots Of Paradigm Quick-set Infusion Sets

Medtronic Recalls Certain Lots Of Paradigm Quick-set Infusion Sets

Medtronic Recalls Certain Lots of Paradigm Quick-Set Infusion Sets Advisory 2009-126 For immediate release OTTAWA - Health Canada is advising Canadians that the company Medtronic has initiated a recall of its Paradigm Quick-set infusion sets with lot numbers beginning with "8" ("Lot 8"). A small percentage of the affected infusion sets may work improperly and may deliver too much or too little insulin, which could cause serious health effects. Medtronic Paradigm Quick-set infusion sets are used by patients with diabetes as part of intensive insulin therapy. An infusion set is a narrow-diameter tube that connects to an insulin pump to deliver insulin to the patient through a needle under the patient's skin. Patients using a Paradigm Quick-set infusion set are advised to check the lot number of their product. (See the instructions provided below.) If the set is from "Lot 8," Medtronic is advising patients to stop using it immediately. Infusion sets from any other lot can be used. Patients can contact Medtronic of Canada directly to arrange the return of any "Lot 8" infusion sets and receive a replacement product. Information about the recall is available on the Medtronic website, or by telephone between 8:30 a.m. and 7:00 p.m. (Eastern time) at 1-800-284-4416. Patients with any questions or concerns regarding a medical device they are using should contact their pharmacist or health care professional. An insulin under-dose could result in high blood sugar (hyperglycemia), while an insulin overdose could lead to low blood sugar (hypoglycemia). Both high and low blood sugar should be recognized and treated promptly to avoid serious complications. The recalled "Lot 8" Quick-set infusion sets were manufactured by Medtronic primarily for distribution in the United States. Limit Continue reading >>

Cgm Sensor Delays Plaguing Medtronic | Diabetesmine

Cgm Sensor Delays Plaguing Medtronic | Diabetesmine

We're sorry, an error occurred. We are unable to collect your feedback at this time. However, your feedback is important to us. Please try again later. Not surprisingly, there's been a lot of hype about Medtronic's new 670G "hybrid closed loop" semi-automated insulin delivery system since it was approved by the FDA just over a year ago. After all, it's the first of its kind -- so far the only "pre-Artificial Pancreas" technology connecting an insulin pump and continuous glucose monitor with smart algorithms that's gotten the green light from regulators, much quicker than anyone expected in fact. Truly, there's a lot to be exited about. Yet despite all the good vibes (and mostly good press), Medtronic has faced a number of speed bumps over the past year -- from the company's slower-than-announced rollout that left many would-be customers frustrated, its inability to keep up with the high demand for CGM sensors and other supplies, to Anthem's initial refusal to cover the 670G, and Hurricane Maria in September hobbling Medtronic's Puerto Rico manufacturing operations. Of course any company can be hit with operational snags, or be affected by a natural disaster. But what makes this particularly alarming for the D-Community is the contracting of the diabetes device market these days, with a Nov. 12 Star Tribune story noting that some now see Medtronic as the "only game in town" for some of these products. With the insulin pump market shrinking and access to diabetes necessities becoming more uncertain, Medtronic is edging ever closer to monopolizing this med-tech segment and that means people with diabetes may not have many options except to make do. Bottom line: Many patients face fewer choices, and are afraid of being left twisting in the wind if they can't even get acces Continue reading >>

Medtronic Faces Major Device Recall

Medtronic Faces Major Device Recall

Any FDA recall is a major downfall for the patients and company involved, but how were the share prices affected? A Class I recallwhich is the most serious of its kindhas been placed on four years worth of cardiac medical devices from Medtronic (NYSE: MDT ). While only 48 patients are affected in the US by this recall, Medtronic must now rebuild trust with its patients and investors. The US Food & Drug Administration (FDA) announced Monday (February 26), some of Medtronics cardiac medical devices manufactured between July 13, 2013 and August 8, 2017 may cause serious injuries or death. Affected devices include cardiac resynchronization therapy (CRT-Ds) and cardiac implantable defibrillators (ICDs), which have a manufacturing error preventing or delaying the electrical shock patients need for their heart to function properly. On January 22, the company sent an urgent medical device recall to patients with the devices offering supplemental device warranty for affected devices. The notice advises patients to consider Prophylactic device replacements who have the implants, contact Medtronic sales representatives for the device warranties and insure medical staff are aware of the notice. According to the statement, as of January 12 Medtronic had confirmed one implanted device failure resulting in loss of high-voltage therapy related to this issue, where th patient was rescued with external defibrillation. Due to the nature of this issue, it is not possible to identify which of these 48 devices may fail or when they may fail, the press release said. Further, we cannot predict how many high-voltage charges can occur prior to a potential failure. Medtronic is a global medical device company working in four different segments: cardiac and vascular, diabetes, restorative therapi Continue reading >>

Medtronic Announces Voluntary Recall Of Diabetes Infusion Sets

Medtronic Announces Voluntary Recall Of Diabetes Infusion Sets

Medtronic Canada, a subsidiary of Medtronic plc (NYSE:MDT), announced today that Medtronic 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 and 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 Health Canada and 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 Med 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 >>

Animas Shuts Down Its Pump Line

Animas Shuts Down Its Pump Line

Johnson & Johnson has decided to disconnect from the insulin pump market, a move that will leave Animas, Animas Vibe, and OneTouch Ping users looking for a new pump. A press release by the company said it has partnered with Medtronic to transition its existing customers to Medtronic’s pump line. Johnson & Johnson representatives cited increased competition as the reason the Animas brand has being discontinued. This news was first reported in the diabetes news sphere by Diabetes Mine on its Facebook page. sponsor The move to pull the plug on the Animas pump brand has long been seen as a possibility by market watchers, but outwardly Johnson & Johnson has professed a “business as usual” attitude with customers. When Diabetic Investor blogger David Kliff wrote about the possibility of consolidation in the insulin pump market in a February 2017 Diabetic Connect article, the company responded to the article by saying, “Animas continues to manufacture, deliver and support its products and provide the service our patients expect. We remain committed to our patients, and we intend to honor our warranty and do not anticipate any interruptions to patients’ pump therapy. If patients or potential patients have any concerns, they can contact Animas online or at 1-877-YES-PUMP.” That number’s phone tree now prompts customers to learn more about the decision to shudder the Animas pump line. I called the number and was connected with a call center operator who read a prepared statement about the transition. It said that customers whose warranties expire on or after September 30th, 2019 will have the option to transition to a Medtronic 630G free of charge; this Medtronic pump automatically suspends insulin delivery should the system’s CGM detect that blood glucose levels Continue reading >>

Manufacturing Defect Leads To Recall Of Implanted Medtronic Crt-d Devices, Icds

Manufacturing Defect Leads To Recall Of Implanted Medtronic Crt-d Devices, Icds

Manufacturing Defect Leads to Recall of Implanted Medtronic CRT-D Devices, ICDs The company is advising physicians to consider explanting the affected devices, used in 48 patients in the United States. A manufacturing defect that prevents delivery of necessary electrical shocks has resulted in the recall of four dozen already-implanted cardiac resynchronization therapy-defibrillation (CRT-D) devices and implantable cardioverter-defibrillators (ICDs) made by Medtronic. The problem causes an out-of-specification gas mixture inside the device that prevents it from working properly, according to an announcement from the US Food and Drug Administration (FDA), which classified the move as a Class I recall, the most serious type. Medtronic sent an Urgent Medical Device Recall notice to affected customers on January 22, 2018, advising physicians to strongly consider explanting the 48 affected devices, which were manufactured between July 13, 2013, and August 8, 2017. The serial numbers of the affected CRT-D devices and ICDs can be found in the FDAs announcement . A company spokesperson told TCTMD in an email that there have been no patient deaths related to the issue. There has been one confirmed device failure in which the device lost functionality, requiring external defibrillation to rescue the patient. Manufacturing processes have been updated to prevent the specific manufacturing sequence associated with this issue from occurring, the spokesperson said. Continue reading >>

Class Action Commenced Against Medtronic November 2007 Health Canada

Class Action Commenced Against Medtronic November 2007 Health Canada

Class Action Commenced Against Medtronic November 2007 Health Canada Medtronic of Canada Ltd. informs Canadian patients of the recall of Sprint Fidelis leads models 6930, 6931, 6948 and 6949 due to potential conductor fractures. Kim Orr Barristers P.C., together with Rochon Genova LLP, have launched a national class action against Medtronic Inc. and Medtronic of Canada Ltd. seeking damages of $550,000,000.00 for the manufacture and sale of defective Sprint Fidelis leads. An implantable defibrillator is a device that monitors the heart for rapid, slow or irregular rhythms. When abnormal rhythms are detected, the defibrillator delivers a shock to the heart to return it to a normal rhythm. The shock is delivered to the heart by way of leads, which are small, insulated wires implanted in the heart and connecting it to the defibrillator. Medtronic, the world's leading manufacturer and seller of heart devices, announced on Sunday, October 14, 2007 that it was recalling its Sprint Fidelis electrical leads because the leads were prone to a defect that caused the leads to malfunction, potentially delivering unnecessary shocks to patients or failing to provide life-saving shocks to patients in need. It is estimated that approximately 268,000 patients have received Sprint Fidelis leads in Canada and elsewhere. By letter dated October 15, 2007, Medtronic notified 13,000 physicians that Sprint Fidelis leads models 6930, 6931, 6948 and 6949 should no longer be implanted due to the defects and requested physicians to return any unused leads to Medtronic. Malfunctioning leads may have contributed to five patient deaths worldwide thus far. Medtronic has suspended sale of all Sprint Fidelis leads and has recommended that physicians stop implanting the leads. Medtronic is urging patients Continue reading >>

Medtronic Minimed Insulin Reservoirs Recalled In Canada

Medtronic Minimed Insulin Reservoirs Recalled In Canada

Medtronic MiniMed insulin reservoirs recalled in Canada Medtronic MiniMed insulin reservoirs recalled in Canada Medtronic Canada Ltd., in consultation with Health Canada, is recalling select lots of Paradigm Medtronic MiniMed Insulin Reservoirs. Posted: Jul 15, 2013 8:03 AM ET | Last Updated: July 15, 2013 Insulin reservoirs are an alternative to injections. (Medtronic) Medtronic Canada Ltd., in consultation with Health Canada, is recalling select lots of Paradigm Medtronic MiniMed Insulin Reservoirs. Medtronic is recalling the lots due to the potential risk of a leak in the reservoir that may result in under-delivery of insulin. As well, if there is an obstruction in the infusion set, the pump alarm may not be triggered. The under-delivery of insulin may cause hyperglycaemia (high blood sugar), and in extreme cases may cause loss of consciousness or death. The reservoirs are an alternative to injections. The pumps deliver insulin into the body throughout the day, giving patients a little more flexibility in their routine. Doctor Arthur Kidd, an endocrinologist at Windsor Regional Hospital, says if a patient uses the device, he or she must closely monitor their condition. He says it's important for diabetics to first learn to manage the illness the traditional way. "If there is a problem with the pump therapy ... the patient falls back to the traditional therapy immediately to maintain their safety," Kidd said. Medtronic Canada Ltd is notifying all customers who have purchased products from them of the recall and advising them to check their supplies to see if they have received affected lots. The lot number can be found on the side panel of the reservoir box and on the packaging of each individual reservoir. The insulin reservoirs are used with Paradigm insulin infusi Continue reading >>

Medtronic Recalls Crt-ds And Icds Due To Manufacturing Error Preventing Electrical Shock Delivery

Medtronic Recalls Crt-ds And Icds Due To Manufacturing Error Preventing Electrical Shock Delivery

News | Cardiac Resynchronization Therapy Devices (CRT) | February 26, 2018 Medtronic Recalls CRT-Ds and ICDs Due to Manufacturing Error Preventing Electrical Shock Delivery Defect cited in Class I recall causes an out-of-specification gas mixture inside the device that may prevent shock delivery February 26, 2018 The U.S. Food and Drug Administration (FDA) announced that Medtronic is recalling certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy devices (CRT-Ds) due to a defect in the manufacturing process. The FDA said 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. On Jan. 22, 2018, Medtronic sent an Urgent Medical Device Recall notice to affected customers. The notice asked customers to: Consider prophylactic device replacement for patients who have been implanted with one of the affected devices; Contact their Medtronic sales representative for terms and conditions for device warranties; and Review the recall notice and ensure appropriate staff is aware of the notice. The recall impacts patients with an affected Medtronic ICD or CRT-D device, caregivers of those patients, and healthcare providers treating patients with heart failure or heart rhythm problems using these devices. The recall affects CRT-Ds an ICDs with product codes NIK and LWS, manufactured between July 13, 2013, and Aug. 8, 2017 a total of 48 units nationwide. Medtronic will offer a supplemental device warranty for affected devices. Customers who have questions or need additional information or support regarding this recall should contact their local Medtronic sales representative or Medtronic Techn Continue reading >>

Update 1-medtronic To Recall Some Diabetes Infusion Sets

Update 1-medtronic To Recall Some Diabetes Infusion Sets

(Adds details) Sept 11 (Reuters) - Medical device maker Medtronic Plc said on Monday it would recall certain infusion sets used with its insulin pumps by diabetes patients due to a component that could cause death in extreme cases. Infusion sets help connect an insulin pump device to the body. Medtronic said the vent membrane in some of its infusion sets could be blocked by fluid during the process of priming, or removal of air bubbles, potentially leading to insulin being over-delivered. Over-delivery of insulin can cause hypoglycemia or low blood sugar and in extreme cases, death. Medtronic said it had discontinued the affected vent membranes in the infusion sets. The Dublin-based company received reports of hypoglycemia requiring medical intervention, potentially linked to the issue, Medtronic said. Medtronic did not provide the number of infusion sets being recalled. The company in April recalled devices used to manage build-up of the cerebrospinal fluid that surrounds the brain due to increased complaints. (Reporting by Manas Mishra in Bengaluru; Editing by Savio D‘Souza and Sai Sachin Ravikumar) 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, 2017 Medscape.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 nee Continue reading >>

Medtronic Recall Specific Lots Of Infusion Sets With All Models Of Medtronic Insulin Pumps

Medtronic Recall Specific Lots Of Infusion Sets With All Models Of Medtronic Insulin Pumps

Medtronic 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 discontinued component in these infusion sets and does not include insulin pumps or glucose sensors. The 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 can lead to potential over-delivery of insulin shortly after an infusion set change, which may cause hypoglycaemia. Currently manufactured infusion sets, available from April 2017, include a design update of this component which the company believes reduces the above risk. 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 and will continue working directly with government and regulatory authorities on this global voluntary recall. Customer Instructions Medtronic recommends that customers use only infusion sets made with the new and enhanced component, the membrane, starting with their next set change. Customers in the United States can determine if they have recalled infusion sets by visiting Customers in Europe, Middle East and Africa (EMEA region) can determine if they have recalled infusion sets by visiting www.mmc.medtronic-diabetes.com/look. Medtronic also advise that patients can always consult the advice of their healthcare professional regarding their medical treatment. Continue reading >>

Medtronic (unomedical) Infusion Sets(2017-09-11)

Medtronic (unomedical) Infusion Sets(2017-09-11)

Medtronic (Unomedical) Infusion Sets(2017-09-11) General Public, Healthcare Professionals, Hospitals Medtronic has become aware of recent reports of potential over-delivery of insulin shortly after an infusion set change. The reported incidence rate requiring medical assistance related to this issue is less than 1 in every 2 million infusion sets. 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. Manufacturer 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 may occur 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. More than 10 numbers, contact manufacturer Continue reading >>

More in diabetes