FDA Safety Warning: Boston Scientific Heart Devices Linked to Injuries and Deaths

Understanding the Risks of Defibrillator Wire Failures and Watchman Implant Complications and How Victims Can Seek Justice

The U.S. Food and Drug Administration has issued safety warnings regarding two Boston Scientific heart devices after reports of serious injuries and deaths. The alerts concern the company’s Endotak Reliance defibrillator wires and the Watchman heart implant. These devices are used in patients with life-threatening heart conditions, making the reported failures a critical public health issue.

Endotak Reliance Defibrillator Wire Failures

The FDA reports that some Endotak Reliance defibrillator wires have become calcified, preventing them from delivering life-saving shocks during cardiac events. Between 2002 and 2021, these wires were widely implanted, and as of July 24, 2025, there have been 386 serious injuries and 16 deaths. Ten deaths were directly linked to device failure, while others occurred during removal surgeries. Replacing or removing these wires carries significant risks, making individualized medical evaluation essential.

Watchman Implant Safety Concerns

The Watchman device is designed to reduce stroke risk by closing part of the heart’s left atrium, offering an alternative to long-term blood thinners. The FDA’s notice warns of increased risks of blood vessel blockages during implantation, with 120 serious injuries and 17 deaths reported as of July 30, 2025. The risk appears linked to the anesthesia level used during the procedure. While the device design remains unchanged, implantation protocols have been updated.

Legal Rights for Affected Patients

Patients harmed by defective medical devices may be entitled to compensation for medical bills, lost income, pain and suffering, and wrongful death damages. Product liability claims against manufacturers can hold them accountable for device defects, inadequate warnings, or procedural hazards. Victims should seek legal advice promptly to protect their rights.

Boston Scientific Medical Device FAQs

What should I do if I have an Endotak Reliance defibrillator or Watchman implant? Contact your cardiologist immediately to discuss the FDA alerts and assess your device’s condition.

Can I file a lawsuit if I was injured?
Yes. If your injury or a loved one’s death is linked to these devices, you may be able to file a personal injury or wrongful death claim.

What evidence is needed?
Medical records, surgical reports, device identification, and proof of injury or death are key.

How can an attorney help?
A lawyer can gather medical evidence, work with expert witnesses, and pursue maximum compensation.

Is there a time limit to file?
Yes. Statutes of limitations vary by state. Immediate legal consultation is essential.

Contact Parker Waichman LLP For A Free Case Review

If you or a loved one suffered harm from a Boston Scientific Endotak Reliance defibrillator or Watchman implant, Parker Waichman LLP can help. Our national personal injury law firm offers free consultations to explain your legal rights and potential compensation. Call 1-800-YOUR-LAWYER (1-800-968-7529) now. Time limits apply—act today to protect your rights.