FDA Issues Safety Warnings on Boston Scientific Heart Devices Linked to Injuries and Fatalities

The U.S. Food and Drug Administration (FDA) has issued safety alerts concerning two Boston Scientific heart devices that have been associated with serious injuries and fatalities. The agency specifically highlighted issues with the company's Endotak Reliance defibrillator wires and the Watchman device used for stroke prevention.

For the defibrillators, the FDA reports that the wires can develop calcification over time, which may lead to device failure in delivering life-saving shocks during cardiac emergencies. This problem has resulted in 386 serious injuries and 16 deaths as reported by Boston Scientific up to July 24. Among the fatalities, ten were attributed to device malfunction, while others involved surgical removal procedures or were deemed unrelated.

These wires were distributed between 2002 and 2021 and are no longer available. Patients with these devices might require replacement, though medical professionals should consider the risks associated with surgical removal.

Separately, the FDA also addressed concerns related to Boston Scientific's Watchman device, which is implanted in the heart's left atrium to reduce stroke risk in patients with atrial fibrillation. The company recently updated its implantation instructions after discovering an increased risk of bloodstream blockages during the procedure, especially depending on anesthesia levels. As of July 30, there have been 120 serious injuries and 17 deaths linked to issues with the Watchman device. A company investigation found that these safety concerns are not related to the design or manufacturing defects.

Boston Scientific's heart-related products are a significant part of its revenue, comprising about two-thirds of its $5 billion quarterly income. The company has alerted healthcare providers to these issues and emphasized careful patient selection and procedural considerations.

Shares of Boston Scientific saw a decrease of approximately 1.8%, closing at $102.95 following the news. Patients and clinicians are advised to stay informed about these safety concerns and consult healthcare professionals for appropriate management.

source: https://medicalxpress.com/news/2025-08-fda-flags-problems-boston-scientific.html