Boston Scientific Flags Safety Concern with Certain Defibrillation Leads

Boston Scientific has alerted healthcare providers about performance issues in specific Endotak Reliance defibrillation leads with ePTFE-coated coils, linked to calcification that can reduce shock effectiveness. The FDA reported 386 serious injuries and 16 deaths, though the company said two were unrelated and emphasized that direct causation cannot be confirmed.

Calcification can electrically insulate the lead coil, potentially preventing proper arrhythmia termination and, in some cases, requiring early device removal. Post-market data linked 10 deaths to rising electrical impedance and failed shock delivery, and four more to complications during lead extraction.

The affected leads, manufactured from 2002 to 2021, are no longer sold but remain implanted in approximately 354,000 patients worldwide. Boston Scientific advises ongoing routine follow-up, as impedance rise is usually detectable years before complications. Physicians are urged to weigh extraction risks against leaving the lead in place, especially in long-term implants with higher calcification risk.

10-08-2025