Medtronic Recalls Crt-ds And Icds: Manufacturing Error May Prevent Electrical Shock Delivery
Medtronic Recalls CRT-Ds and ICDs: Manufacturing Error May Prevent Electrical Shock Delivery Defect in manufacturing process causes an out of specification gas mixture inside the device. Certain models of the Amplia MRI CRT-D are subject to the recall. Image courtesy of Medtronic. U.S. Food and Drug Administration02.26.18 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 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 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 >>
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 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 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 48 Crm Devices On Arcing Risk
February 27, 2018 By Brad Perriello Leave a Comment Medtronic (NYSE: MDT ) informed physicians last month of a problem with 48 of its cardiac rhythm management devices prompting a Class I recall of the devices. The recall affects cardiac resynchronization therapy defibrillators and implantable cardioverter defibrillators that were sent through a manufacturing sequence that introduced the potential for internal arcing during high-voltage charging, leading to the immediate and permanent loss of device functionality, according to a January doctors letter from quality & regulatory VP Tim Samsel. The issue led to a single instance in which an implanted device failed, in which external defibrillation was required to rescue the patient. The affectedCRT-Ds are from Fridley, Minn.-based Medtronics Amplia, Claria, Compia and Viva lines. The ICDs involved in the recall are from theEvera and Visia lines. 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. Further, we cannot predict how many high-voltage charges can occur prior to a potential failure, Samsel wrote. Continue reading >>
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 Insulin Infusion Sets
Medtronic recalled some of the infusion sets used with its insulin pumps due to problems with a discontinued component. The company said the problem involves a vent membrane that’s susceptible to blockage during priming and fill-tubing. No pumps or glucose sensors are affected by the recall. Infusion sets made since April 2017 use an updated vent membrane design. 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 >>
Patients Facing Revision Surgery After Medtronic Recall
Patients facing revision surgery after Medtronic recall Dozens of U.S. patients may have to undergo surgery to replace their Medtronic heart defibrillators following the discovery of a manufacturing problem that could render the devices unable to provide life-saving electric shocks. Medtronic has recalled 48 implantable cardioverter defibrillators (ICDs) and cardiac resychronization therapy defibrillators (CRT-Ds). On Monday the U.S. Food and Drug Administration classified the move as a Class 1 recall, the highest-severity category involving potentially life-threating problems. A company spokeswoman said Medtronic has notified the physicians providing care for the 48 patients whose devices are affected by the recall. With the support of the Independent Physician Quality Panel, Medtronic has advised that physicians strongly consider explanting these 48 devices, spokeswoman Tracy McNulty said via email. An implantable defibrillator is a battery-powered device that monitors heart activity and can automatically give low-voltage or high-voltage electric shocks to correct a heartbeat that is too slow, too fast, or dangerously erratic. There have been no reported deaths as a result of the issue that led to the recall. One patient did need to be rescued with an external defibrillator after their implanted device failed, McNulty wrote. The company has updated its manufacturing processes to prevent the issue from happening in the future. Medtronic sells many thousands of defibrillators each year. The 48 individual devices are identified by model and serial number in the FDA recall notice, which is available here . Continue reading >>
Medtronic Pacemaker Recall
Update: Critics Increase Scrutiny of Medtronic-Researcher Ties The cozy relationship between doctors reporting on their research and Medtronic, a medical device company paying them royalties and consulting fees, continues to be investigated by an increasing number of critics. Faultfinders question the potential influence Medtronics payments may have had on the investigators scientific judgment and their published reports. Looking into this relationship, to mention a few, are The Milwaukee Journal Sentinel, MedPage Today, The New York Times, The Wallstreet Journal, a U.S. Senate Finance Committee, and a Senate Special Committee on Aging. Doctors who co-authored reports on clinical studies of a bone fusion product called Infuse Bone Graft made no mention or downplayed adverse effects of using the product in spinal fusion surgery or other spinal surgeries, according to editorials and other articles in The Spine Journal. The journal devoted an entire issue to questioning the doctor-Medtronic relationship. The doctors, 15 surgeons, failed to reveal in 13 published clinical studies any adverse reactions to Infuse and the millions of dollars they were receiving from Medtronic. Payment data indicate that some authors had associations with Medtronic valued at more than $10 million. Other researchers were reporting side effects from the bone fusion product. Complications and adverse events range from excess cancers and serious inflammatory reactions to fertility problems caused by retrograde ejaculation and radiating leg pain, reports MedPage Today. The under-reporting of adverse events in the 13 original reports was most troublesome, Carragee and colleagues suggested, MedPage Today reported June 28, 2011. Eugene Carragee, M.D., is at Stanford Universitys outpatient clinic in Re Continue reading >>
Medtronic Diabetes Infusion Sets
On September 7, 2017, Medtronic announced a voluntary recall of specific lots of their Diabetes Infusion Sets used with all models of Medtronic insulin pumps. The recall is associated with problems with a component in these sets. The vent membrane can be blocked by fluid, which could lead to excessive delivery to insulin to patients, with the risk of causing hypoglycemia or even death. Medtronic MiniMed Infusion Sets: Global Recall of Specific Sets People who have been using the Diabetes Infusion Set manufactured by Medtronics may have suffered a serious medical emergency directly related to the over-delivery of insulin. People who suffer injury from the use of one of these medical devices have the right to seek full monetary compensation for all damages. At Meyers & Flowers, our team of trial attorneys are advocates for the injured in cases of faulty medical devices. We can assist you to file a claim for compensatory damages if you or a loved one has suffered an adverse effect in using a Medtronics Diabetes Infusion Set. We urge you to connect with us immediately for more information on this important matter. Recall of Medtronics Diabetes Infusion Sets After Reports of Medical Emergencies This global recall of the Medtronics Diabetes Infusion Set was initiated after reports of hypoglycemia requiring medical intervention with patients using this defective product. Manufacturers of medical devices are held to a high standard – as they should be. In the case of patients requiring a specific safe dose of insulin for blood sugar level stability, the over-delivery of insulin can cause the body to absorb far too much blood sugar, leading to dangerously low blood glucose levels, a condition called hypoglycemia. Symptoms of Hypoglycemia Sweating, clamminess Chills Dizziness L Continue reading >>
Medtronic Recalls 48 Crm Devices On Arcing Risk
Home Medtronic recalls 48 CRM devices on arcing risk Medtronic recalls 48 CRM devices on arcing risk Medtronic (NYSE: MDT ) informed physicians last month of a problem with 48 of its cardiac rhythm management devices thats prompting a Class I recall of the devices. The recall affects cardiac resynchronization therapy defibrillators and implantable cardioverter defibrillators that were sent through a manufacturing sequence that introduced the potential for internal arcing during high-voltage charging, leading to the immediate and permanent loss of device functionality, according to a January doctors letter from quality & regulatory VP Tim Samsel. The issue led to a single instance in which an implanted device failed, in which external defibrillation was required to rescue the patient. The affectedCRT-Ds are from Fridley, Minn.-based Medtronics Amplia, Claria, Compia and Viva lines. The ICDs involved in the recall are from theEvera and Visia lines. 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. Further, we cannot predict how many high-voltage charges can occur prior to a potential failure, Samsel wrote. Tests on a small number of devices made using the same technique showed that the failure occurred in 23% of devices; 7.7% of the tested devices failed within the first two high-voltage charges, the company said in the letter. The FDA yesterday gave the recall Class I status , denoting the risk of serious injury or death. Patients implanted with the affected devices might need to have them replaced, according to the letter. Prophylactic device replacement should be strongly considered for patients who have been implanted with one of the devices listed in Appendix A . Medtronic Continue reading >>
Newsroom | Medtronic | 2018 Press Releases
New Analyses Confirm Patients with Medtronic CRT Devices Experience Less Atrial Fibrillation, Are More Active Positive Data on Exclusive AdaptivCRT(TM) Feature Unveiled at EHRA Scientific Sessions 2018 DUBLIN and BARCELONA, Spain - March 20, 2018 - Two real-world analyses featuring the Medtronic plc (NYSE: MDT) AdaptivCRT(TM) algorithm reinforce that its use is linked to a reduction in atrial fibrillation (AF) episodes, as well as tied to higher patient activity levels. The results, involving 408 patients with heart failure and a Medtronic cardiac resynchronization therapy (CRT) device at 26 centers i... Study Shows Positive Results with Medtronic Cryoballoon for Patients with Persistent Atrial Fibrillation DUBLIN and BARCELONA, Spain - MARCH 19, 2018 - Medtronicplc (NYSE: MDT) today announced one-year results from the CRYO4PERSISTENT AF study of ablation with the Arctic Front Advance(TM) Cryoballoon to isolate the pulmonary veins in patients with symptomatic persistent atrial fibrillation (AF). The Arctic Front Advance Cyroablation System is not approved for treating persistent AF in the United States. The study results, presented today at the European Heart Rhythm Association (EHRA) Scientific ... Medtronic EVP & President Hooman Hakami to Speak at Oppenheimer Healthcare Conference DUBLIN - March 13, 2018 - Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced it will participate in the Oppenheimer 28th Annual Healthcare Conference on Tuesday, March 20, 2018, in New York City. Hooman Hakami, executive vice president and group president of Medtronic's Diabetes Group, will answer questions about the company beginning at 8:35 a.m. EDT (7:35 a.m. CDT). A live audio webcast of the presentation will be available on March 20, 2018, by clicking o Continue reading >>
Fda: Class I Recall Of 48 Medtronic Icds, Crt-ds
FDA: Class I Recall of 48 Medtronic ICDs, CRT-Ds The US Food and Drug Administration (FDA) has declared a class I recall of a limited number of implantable defibrillators from Medtronic, including some with biventricular pacing capability, because of a manufacturing defect. "This defect causes an out-of-specification gas mixture inside the device" that could cause it to fail to deliver high- or low-voltage therapy (that is, shocks or pacing), according to the agency. The recall applies to 48 individual devices , listed by their serial numbers, that include Medtronic Evera and Visia implantable cardioverter-defibrillators (ICDs) and Amplia, Claria, Compia, and Viva cardiac resynchronization therapy-defibrillators (CRT-Ds). On January 22, Medtronic instructed clinicians to "consider prophylactic device replacement for patients who have been implanted with one of the affected devices." Follow Steve Stiles on Twitter: @SteveStiles2 . For more from theheart.org | Medscape Cardiology, follow us on Twitter and Facebook . Cite this article: FDA: Class I Recall of 48 Medtronic ICDs, CRT-Ds-Medscape-Feb27,2018. Continue reading >>
