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Early Alert: Defibrillation Lead Issue from Boston Scientific
The FDA is aware that Boston Scientific has issued a letter notifying affected customers that certain ENDOTAK RELIANCE Defibrillation leads with expanded polytetrafluoroethylene (ePTFE) coated coils may impact shock efficacy and/or require early replacement.
The most common harm is early lead replacement, and the most serious harm is death or need for cardiac resuscitation due to non-conversion of a sustained ventricular arrhythmia from a reduced shock energy due to high impedance.
As of July 24, Boston Scientific has reported 386 serious injuries and 16 patient deaths associated with this issue.
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Boston Scientific at tech.services@bsci.com or call 1-800-227-3422.
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