Medtronic Defibrillator: News, Research, and Lawsuits

Medtronic has long been at the forefront of cardiac care with its implantable defibrillators. These devices are designed to prevent sudden cardiac death.

While their products have saved countless lives, Medtronic has also faced legal challenges. These include a class action lawsuit stemming from a major recall of defibrillators due to a defect in a critical component of the device.

This article explores the latest news, research, and legal action surrounding Medtronic’s defibrillator products. If you have been injured by a Medtronic medical device, you can also talk to a product liability attorney in 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.

What Is a Defibrillator?

A defibrillator is a medical device designed 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.

The most common types of defibrillators include:

• Automated External Defibrillators: Portable devices found in public places that can be used by bystanders
• Implantable Cardioverter Defibrillators: Surgically implanted devices that continuously monitor heart rhythms and deliver shocks when dangerous arrhythmias are detected

• Wearable Cardioverter Defibrillators: External devices worn like a vest that monitor the heart and deliver shocks when necessary

The Medtronic”Sprint Fidelis”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.

Timeline of Medtronic Defibrillator News

Follow along for important developments in the history of Medtronic’s defibrillator products including safety alerts, major recalls, and legal updates. Recent developments are listed first and follow in reverse chronological order.

March 18, 2025: Massachusetts Medtronic Defibrillator Case Dismissed

The U.S. District Court for Massachusetts dismissed 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.

The court ruled in favor of Medtronic, granting its motion to dismiss. The judge found that the patient’s claims were preempted by the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act. These amendments limit state-level legal actions against FDA-approved medical devices.

The court also determined that the patient had not provided enough evidence to support the claims.

August 1, 2023: Class Action Lawsuit Filed and Later Dismissed

A patient who had a recalled defibrillator surgically implanted filed a class action lawsuit related 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.

The court ultimately granted Medtronic’s motion to dismiss the case. 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.

July 18, 2023: Medtronic Recalls 348,000 Defibrillators and CRT-Ds

Medtronic recalled over 348,000 implantable heart devices, including defibrillators and cardiac resynchronization therapy defibrillators (CRT-Ds), due to a serious safety issue. Affected products include:

• Cobalt XT, Cobalt, Crome ICDs and CRT-Ds
• Claria MRI, Amplia MRI, Compia MRI, Viva, Brava CRT-Ds
• Visia AF, Visia AF MRI, Evera, Evera MRI, Primo MRI, Mirro MRI ICDs

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.

The FDA classified this as a Class I recall (the most serious type), as the malfunction could lead to severe injury or death.

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 to reprogram them to reduce risk.

October 14, 2010: Medtronic Agrees to Settlement

Medtronic Inc. agreed to a $268 million settlement to resolve lawsuits in the United States related to a defective component used in its implantable heart defibrillators.

The issue involved the Sprint Fidelis leads, which were recalled three years prior after it was discovered that certain models had wire fractures. These wires are critical as they connect the defibrillator device to the heart.

October 15, 2007: Warning on Faulty Defibrillator Component

Defibrillator manufacturer Medtronic Inc. warned patients and health care providers that an electrical wire (called a”lead”) that links the defibrillator to the heart could fracture. Medtronic announced that it is voluntarily suspending all distribution of the”Sprint Fidelis”leads. Medtronic defibrillators have included the Fidelis lead since 2004.

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”audible alerts, inappropriate shocks and/or loss of output.”The company identified five deaths in which a Sprint Fidelis lead fracture”may have been a possible or likely contributing factor.”

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.

November 28, 2006: Court Denies Request to Dismiss Medtronic Suits

Medtronic, Inc. announced that a Minnesota District Court has denied its request to dismiss numerous defective product lawsuits over the company’s recalled implantable heart defibrillators. Medtronic has argued that U.S. Food and Drug Administration (FDA) regulations (and the FDA’s approval of the defibrillators) should preempt the lawsuits.

Although Medtronic plans to appeal the decision, the court’s denial of the company’s request for dismissal could lead to an out-of-court settlement of some claims.

August 18, 2006: Medtronic Sued Over Faulty Pacemaker

A West Virginia resident filed suit against Medtronic, Inc., alleging that the battery powering his pacemaker could fail at any time. This was a 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.

February 11, 2005: Medtronic Issues Notification on Certain Defibrillators

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.

Health Complications From a Medtronic Defibrillator? Get Legal Advice

Medical device manufacturers have a legal duty to ensure their products are safe and free of defects before they reach the market. If you’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.

An attorney near you familiar with your state laws can help you understand your rights and whether you have a case. They can guide you through the process of a product liability lawsuit or personal injury lawsuit.