FDA Updates Boston Scientific Defibrillation Lead Recall After 16 Deaths Reported

The U.S. Food and Drug Administration (FDA) has issued a correction notice related to the recall of Boston Scientific Endotak Reliance defibrillation leads, a widely used medical device designed to restore normal heart rhythm during cardiac arrest. The FDA classified this recall as the most serious type because of the potential for life-threatening consequences if the issue is not corrected.

The Scope of the Recall

The recall does not require removal of the devices already implanted in patients or taken off the market entirely. Instead, it involves correcting affected devices and updating monitoring protocols. Despite this limited action, the potential dangers are severe. According to Boston Scientific and the FDA, there have been:

• 386 reported serious injuries

• 16 reported patient deaths

linked to the affected defibrillation leads.

What’s Wrong with the Devices?

The problem stems from certain Endotak Reliance leads that use an expanded polytetrafluoroethylene (ePTFE) coating on the coils. Over time, these coils can calcify, creating an insulating layer that interferes with the electrical signals.

In practical terms, this calcification may:

• Cause a gradual rise in low voltage shock impedance (LVSI) readings

• Encapsulate the lead coils, preventing full delivery of shock energy

• Lead to failure in restoring normal heart rhythm during a cardiac arrest

In many cases, the harm reported has been early lead replacement. But in the most serious outcomes, this failure has led to death or the need for emergency resuscitation.

FDA and Boston Scientific Guidance for Patients and Providers

Boston Scientific sent out letters in July 2025 alerting healthcare providers to the risks associated with the affected leads. Both the company and the FDA now recommend that:

• Healthcare providers continue regular monitoring (in-person or remote) of patients with affected devices.

• Clinicians should check the 28-day average LVSI and review high voltage shock impedance (HVSI) from the most recent episodes.

• If replacement is considered, doctors must weigh the risks of lead extraction against abandonment, since lead removal itself carries risks.

This guidance underscores that, while immediate device removal isn’t required, proactive monitoring is critical to patient safety.

Why This Matters for Patients

For patients and families, this recall highlights a devastating reality: even life-saving medical devices can pose hidden dangers. Defibrillation leads are implanted in vulnerable patients who rely on them to prevent sudden cardiac death. If those devices fail at a critical moment, the results can be catastrophic.

The FDA’s correction emphasizes that patients should not stop or delay their follow-ups. Instead, they should work closely with their cardiologists to ensure their devices are functioning properly and that any concerning patterns are detected early.

Broader Concerns with Medical Device Safety

The Boston Scientific recall adds to a growing list of medical device recalls that raise serious questions about manufacturing standards, long-term safety testing, and regulatory oversight. When companies like Boston Scientific — one of the largest players in cardiovascular medicine — face recalls tied to patient deaths, it signals the need for stronger protections.

Patients and their families deserve transparency, accountability, and timely warnings when device problems are identified. Unfortunately, as we’ve seen in other cases, recalls often follow years of reported injuries.

Background on Boston Scientific’s History of Recalls and Lawsuits

This is not the first time Boston Scientific has faced scrutiny over patient safety. In past years, the company has been involved in major litigation over its transvaginal mesh implants, which resulted in thousands of lawsuits and significant settlements due to severe complications reported by patients. Boston Scientific has also previously recalled certain cardiac devices, including defibrillators and pacemaker components, for defects that posed risks of serious injury or death. At KBD Attorneys, we have consistently monitored and written about dangerous device recalls like these because patients and families deserve transparency, accountability, and justice when powerful medical device companies put profits before safety.

For more information on Boston Scientific recalls and other related medical device recalls got o our page.

Medical Device and Diagnostic Industry

A recent report from Medical Device and Diagnostic Industry (MD+DI) reconfirmed the seriousness of the Boston Scientific Endotak Reliance defibrillation lead recall. The report highlights that when lead impedance exceeds 150 ohms, there may be as much as a 10% risk of life-saving shocks failing. While the structural and electrical integrity of the leads is generally maintained, shock delivery performance can decline over time due to calcification. Importantly, Boston Scientific has stopped distributing new implants of the affected lead types, meaning this issue now only affects patients who already have the devices.

KBD Attorneys: Protecting Patients Harmed by Defective Medical Devices

At Ketterer, Browne & Davani (KBD Attorneys), we fight for patients and families harmed by defective or dangerous medical devices. Our firm has handled cases involving defective implants, surgical products, catheters, and other life-sustaining devices that caused unnecessary injuries and deaths.

When corporations fail to adequately test or monitor their products — or delay action after learning of risks — patients pay the price. Families who trusted these devices deserve justice.

If you or a loved one has suffered complications related to a Boston Scientific defibrillator lead or another defective medical device, you may have legal options. Our team can:

• Investigate whether your device is linked to the recall

• Work with medical experts to evaluate your injury

• Pursue claims against manufacturers that put profit over patient safety

Stay Informed and Take Action

The FDA has provided a full list of the affected Endotak Reliance defibrillation leads and instructions for healthcare providers and patients. If you have an implanted Boston Scientific device, consult your doctor and ensure you’re receiving the appropriate follow-up care.

Source:

• MassDevice — FDA updates Boston Scientific defibrillation recall related to 16 deaths

• U.S. Food and Drug Administration — Update on Alert: Defibrillation Lead Issue from Boston Scientific

• mddionline.com