{"id":353311,"date":"2016-04-04T10:46:48","date_gmt":"2016-04-04T15:46:48","guid":{"rendered":"https:\/\/content.findlaw-admin.com\/ability-law\/injury\/product-liability\/medtronic-defibrillator-recent-news.html"},"modified":"2025-07-29T13:43:54","modified_gmt":"2025-07-29T18:43:54","slug":"medtronic-defibrillator-recent-news","status":"publish","type":"page","link":"https:\/\/www.findlaw.com\/injury\/product-liability\/medtronic-defibrillator-recent-news.html","title":{"rendered":"Medtronic Defibrillator: News, Research, and Lawsuits"},"content":{"rendered":"\n<div class=\"wp-container-core-columns-is-layout-9d6595d7 fl-sectionWithSidebar fl-container fl-flex fl-flex-wrap fl-gap30\">\n<div class=\"fl-page-articles fl-section-main fl-section-main-full-width\"><h1 class=\"fl-no-margin-top\">Medtronic Defibrillator: News, Research, and Lawsuits<\/h1>\n\n<section class=\"fl-gutenberg-byline\">\n    <div class=\"fl-gutenberg-byline-content\">\n                    By <a href=\"https:\/\/www.findlaw.com\/company\/our-team\/natalie-moritz\/\">Natalie Moritz<\/a> | Legally reviewed by <a\n                href=\"https:\/\/www.findlaw.com\/company\/our-team\/jordan-walker-j-d\/\">Jordan Walker, J.D.<\/a>\n                | Last reviewed\n        <time>\n                            July 29, 2025\n                    <\/time>\n    <\/div>\n\n    \n    <details class=\"fl-gutenberg-byline-toggle fl-gutenberg-byline-legally-reviewed\">\n        <summary>\n            <i class=\"fl-gutenberg-byline-icon\" aria-hidden=\"true\"><\/i>\n            Legally Reviewed\n        <\/summary>\n\n        <div class=\"fl-gutenberg-byline-toggle-content\">\n            <p><em>This article has been written and reviewed for legal accuracy, clarity, and style by <a href=\"https:\/\/www.findlaw.com\/company\/our-team.html\">FindLaw\u2019s team of legal writers and attorneys<\/a> and in accordance with <a href=\"https:\/\/www.findlaw.com\/company\/company-history\/editorial-policy.html\">our editorial standards<\/a>.<\/em><\/p>\n\n        <\/div>\n    <\/details>\n\n    <details class=\"fl-gutenberg-byline-toggle fl-gutenberg-byline-fast-checked\">\n        <summary>\n            <i class=\"fl-gutenberg-byline-icon\" aria-hidden=\"true\"><\/i>\n            Fact-Checked\n        <\/summary>\n\n        <div class=\"fl-gutenberg-byline-toggle-content\">\n            <p><em>The last updated date refers to the last time this article was reviewed by FindLaw or one of our <a href=\"https:\/\/www.findlaw.com\/company\/our-team\/contributing-authors.html\">contributing authors<\/a>. We make every effort to keep our articles updated. For information regarding a specific legal issue affecting you, please <a href=\"https:\/\/lawyers.findlaw.com\/?fli=bylinelink\" target=\"_blank\" rel=\"noopener\">contact an attorney in your area<\/a>.<\/em><\/p>\n\n        <\/div>\n    <\/details>\n<\/section>\n\n\n    <div class=\"fl-callout-text article-blockquote\">\n        <p>Medtronic has faced growing scrutiny over safety issues tied to its implantable defibrillators. A major recall of over 348,000 devices due to a defect that may prevent life-saving shocks has led to injuries, lawsuits, and public concern.<\/p>\n\n    <\/div>\n\n\n\n<div>\n<p>Medtronic has long been at the forefront of cardiac care with its implantable defibrillators. These devices are designed to prevent sudden cardiac death.<\/p>\n<p>While their products have saved countless lives,\u00a0Medtronic has also\u00a0faced legal challenges. These include a\u00a0<a href=\"https:\/\/www.findlaw.com\/litigation\/legal-system\/class-action-cases.html\">class action lawsuit<\/a>\u00a0stemming from a major recall of defibrillators due to a defect in a critical component of the device.<\/p>\n<p>This article explores the latest news, research, and legal action surrounding Medtronic&#8217;s defibrillator products. If you have been injured by a Medtronic medical device, you can also talk to a\u00a0<a href=\"https:\/\/lawyers.findlaw.com\/products-liability-law\/?fli=dcta\" target=\"_blank\" rel=\"noopener\">product liability attorney<\/a>\u00a0in your area. An attorney can evaluate your situation to determine if you have a legal claim. If so, they will advocate for you throughout the legal process and seek fair compensation.<\/p>\n<h2>What Is a Defibrillator?<\/h2>\n<p>A\u00a0<a href=\"https:\/\/www.nhlbi.nih.gov\/health\/defibrillators\/how-do-defibrillators-work\" target=\"_blank\" rel=\"noopener\">defibrillator is a medical device<\/a>\u00a0designed to deliver a controlled electric shock to the heart in order to correct life-threatening arrhythmias, or problems with heart rhythm. These abnormal rhythms can prevent the heart from pumping blood effectively, leading to sudden cardiac arrest.<\/p>\n<p>The most common types of defibrillators include:<\/p>\n<ul>\n<li><strong data-redactor-tag=\"strong\">Automated External Defibrillators<\/strong>: Portable devices\u00a0<a href=\"https:\/\/www.osha.gov\/aed\" target=\"_blank\" rel=\"noopener\">found in public places<\/a>\u00a0that can be used by bystanders<\/li>\n<li><strong data-redactor-tag=\"strong\">Implantable Cardioverter Defibrillators:\u00a0<\/strong>Surgically implanted devices that continuously monitor heart rhythms and deliver shocks when dangerous arrhythmias are detected<\/li>\n<\/ul>\n<ul>\n<li><strong data-redactor-tag=\"strong\">Wearable Cardioverter Defibrillators<\/strong>: External devices worn like a vest that monitor the heart and deliver shocks when necessary<\/li>\n<\/ul>\n<p>The Medtronic &#8220;Sprint Fidelis&#8221; defibrillator is an implantable cardioverter-defibrillator lead (ICD), not a complete defibrillator device. It was designed to deliver therapy from an ICD to the heart to correct abnormal heart rhythms.<\/p>\n<h2>Timeline of Medtronic Defibrillator News<\/h2>\n<p>Follow along for important developments in the history of Medtronic&#8217;s defibrillator products\u00a0including safety alerts, major recalls, and legal updates. Recent developments are listed first and follow in reverse chronological order.<\/p>\n<h3>March 18, 2025: Massachusetts Medtronic Defibrillator Case Dismissed<\/h3>\n<p>The\u00a0<a href=\"https:\/\/www.mad.uscourts.gov\/\" target=\"_blank\" rel=\"noopener\">U.S. District Court for Massachusetts<\/a>\u00a0dismissed a lawsuit filed by a patient against Medtronic, Inc. The patient alleged that three Medtronic implanted devices were defective, ultimately leading to cardiac arrest and emergency surgery. The patient brought claims for negligence and breach of warranty, arguing that the devices were unsafe and failed to perform as intended.<\/p>\n<p>The court ruled in favor of Medtronic, granting its motion to dismiss. The judge found that the patient&#8217;s claims were preempted by the\u00a0<a href=\"https:\/\/www.fda.gov\/medical-devices\/overview-device-regulation\/history-medical-device-regulation-oversight-united-states\" target=\"_blank\" rel=\"noopener\">Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act<\/a>. These amendments limit state-level legal actions against FDA-approved medical devices.<\/p>\n<p>The court also\u00a0determined that the patient had not\u00a0<a href=\"https:\/\/www.findlaw.com\/hirealawyer\/choosing-the-right-lawyer\/evidence-law.html\">provided enough evidence<\/a>\u00a0to support the claims.<\/p>\n<h3>August 1, 2023: Class Action Lawsuit Filed and Later Dismissed<\/h3>\n<p>A patient who had a recalled defibrillator surgically implanted\u00a0<a href=\"https:\/\/caselaw.findlaw.com\/court\/us-dis-crt-d-min\/116091418.html\" target=\"_blank\" rel=\"noopener\">filed a class action lawsuit<\/a>\u00a0related to the 2023 defibrillator recall. The class action suit, filed in U.S. District Court for the District of Minnesota, alleged Medtronic failed to ensure the quality and safety of a range of its defibrillators.<\/p>\n<p>The court ultimately granted Medtronic&#8217;s motion to\u00a0<a href=\"https:\/\/www.findlaw.com\/litigation\/going-to-court\/what-is-a-motion-to-dismiss.html\">dismiss the case<\/a>. The court did not find sufficient factual support in the complaint to establish a plausible claim under federal law. It also acknowledged the FDA had advised against proactively replacing the devices, instead recommending reprogramming and monitoring.<\/p>\n<h3>July 18, 2023: Medtronic Recalls 348,000 Defibrillators and CRT-Ds<\/h3>\n<p>Medtronic\u00a0<a href=\"https:\/\/www.fda.gov\/medical-devices\/medical-device-recalls\/medtronic-recalls-implantable-cardioverter-defibrillators-icds-and-cardiac-resynchronization-therapy\" target=\"_blank\" rel=\"noopener\">recalled over 348,000 implantable heart devices<\/a>, including defibrillators and cardiac resynchronization therapy defibrillators (CRT-Ds), due to a serious safety issue. Affected products include:<\/p>\n<ul>\n<li>Cobalt XT, Cobalt, Crome ICDs and CRT-Ds<\/li>\n<li>Claria MRI, Amplia MRI, Compia MRI, Viva, Brava CRT-Ds<\/li>\n<li>Visia AF, Visia AF MRI, Evera, Evera MRI, Primo MRI, Mirro MRI ICDs<\/li>\n<\/ul>\n<p>A defect in certain models made after 2017 may cause them to deliver too little or no energy during high-voltage therapy. This can potentially fail to treat life-threatening heart problems.<\/p>\n<p>The FDA classified this as a\u00a0<a href=\"https:\/\/www.fda.gov\/safety\/industry-guidance-recalls\/recalls-background-and-definitions\" target=\"_blank\" rel=\"noopener\">Class I recall<\/a>\u00a0(the most serious type), as\u00a0the malfunction could lead to severe injury or death.<\/p>\n<p>To date, Medtronic has reported 28 incidents and 22 injuries, but no deaths. The company is advising doctors not to replace the devices unless necessary, but rather\u00a0to reprogram them to reduce risk.<\/p>\n<h3>October 14, 2010: Medtronic Agrees to Settlement<\/h3>\n<p>Medtronic Inc. agreed to a\u00a0<a href=\"https:\/\/www.reuters.com\/article\/business\/medtronic-to-settle-suits-over-defibrillator-leads-idUSN14103814\/\" target=\"_blank\" rel=\"noopener\">$268 million settlement<\/a>\u00a0to resolve lawsuits in the United States related to a defective component used in its implantable heart defibrillators.<\/p>\n<p>The issue involved the Sprint Fidelis leads, which were\u00a0<a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfres\/res.cfm?id=65383\" target=\"_blank\" rel=\"noopener\">recalled three years<\/a>\u00a0prior after it was discovered that certain models had wire fractures. These wires are critical as they connect the defibrillator device to the heart.<\/p>\n<h3>October 15, 2007: Warning on Faulty Defibrillator Component<\/h3>\n<p>Defibrillator manufacturer Medtronic Inc.\u00a0<a href=\"https:\/\/www.medtronic.com\/en-us\/healthcare-professionals\/product-resources\/product-advisories-performance.html\" target=\"_blank\" rel=\"noopener\">warned patients and health care providers<\/a>\u00a0that an electrical wire (called a &#8220;lead&#8221;) that links the defibrillator to the heart could fracture. Medtronic announced that it is voluntarily suspending all distribution of the &#8220;Sprint Fidelis&#8221; leads. Medtronic defibrillators have included the Fidelis lead since 2004.<\/p>\n<p>According to a press release from Medtronic, Inc., the estimated 268,000 patients who have been implanted with Sprint Fidelis leads might experience lead fractures as &#8220;audible alerts, inappropriate shocks and\/or loss of output.&#8221; The company\u00a0identified five deaths\u00a0in which a Sprint Fidelis lead fracture &#8220;may have been a possible or likely contributing factor.&#8221;<\/p>\n<p>Medtronic did not recommend replacement of the leads. This is because risks posed by implanting a different lead are greater than risks presented by the fracture of the Sprint Fidelis lead.<\/p>\n<h3>November 28, 2006: Court Denies Request to Dismiss Medtronic Suits<\/h3>\n<p>Medtronic, Inc. announced that a Minnesota District Court has denied its request to dismiss numerous defective product lawsuits over the company&#8217;s recalled implantable heart defibrillators. Medtronic has argued that\u00a0<a href=\"https:\/\/www.fda.gov\/\" target=\"_blank\" rel=\"noopener\">U.S. Food and Drug Administration<\/a>\u00a0(FDA) regulations (and the FDA&#8217;s approval of the defibrillators) should preempt the lawsuits.<\/p>\n<p>Although Medtronic plans to\u00a0<a href=\"https:\/\/www.findlaw.com\/criminal\/criminal-procedure\/appeals-appellate-courts-and-costs.html\">appeal the decision<\/a>, the court&#8217;s denial of the company&#8217;s request for dismissal could lead to an\u00a0<a href=\"https:\/\/www.findlaw.com\/litigation\/legal-system\/what-does-it-mean-to-settle-a-case.html\">out-of-court settlement<\/a>\u00a0of some claims.<\/p>\n<h3>August 18, 2006: Medtronic Sued Over Faulty Pacemaker<\/h3>\n<p>A West Virginia resident filed suit against Medtronic, Inc., alleging that the battery powering his pacemaker could fail at any time. This was\u00a0a possibility that the company acknowledged in 2005. The plaintiff had the Marquis DR ICD Model 7274 implanted in 2002, and was told that the battery would last for 25 years.<\/p>\n<h3>February 11, 2005: Medtronic Issues Notification on Certain Defibrillators<\/h3>\n<p>The U.S. Food and Drug Administration (FDA) announced that Medtronic has issued a notification regarding certain implantable defibrillator models. Medtronic voluntarily advised physicians about a potential battery-shorting mechanism that may occur in a subset of implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy-defibrillator (CRT-D) models.<\/p>\n<h2>Health Complications From a Medtronic Defibrillator? Get Legal Advice<\/h2>\n<p>Medical device manufacturers have a legal duty to ensure their products are safe and free of defects before they reach the market. If you&#8217;ve suffered a serious injury from a defibrillator or other medical device, you may have a legal claim. You could be entitled to compensation for medical expenses, pain and suffering, and other losses.<\/p>\n<p>An\u00a0<a href=\"https:\/\/lawyers.findlaw.com\/products-liability-law\/?fli=dcta\" target=\"_blank\" rel=\"noopener\">attorney near you<\/a>\u00a0familiar with your state laws can help you understand your rights and whether you have a case. 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