The FDA has issued an alert regarding a safety concern with certain Boston Scientific defibrillator leads used in implantable cardioverter defibrillators.
The affected models include Endotak Reliance, Reliance 4-site and Reliance 4-front defibrillation leads that use an expanded polytetrafluoroethylene-coated coil, according to an Aug. 6 news release from the agency.
The calcification of the defibrillation lead coils in the models may impair the device’s ability to deliver life-saving shocks during cardiac events. The affected leads may remain in the body for eight or more years before showing signs of failure, the release said.
Boston Scientific has reported 386 serious injuries and 16 patient deaths.
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