Boston Scientific is recalling ENDOTAK RELIANCE and RELIANCE 4-FRONT transvenous defibrillation leads, with 247,702 units affected in the United States. These implantable leads can experience calcium buildup on the lead coils, causing a gradual increase in electrical resistance. This defect may prevent the device from functioning correctly and could require the lead to be replaced earlier than expected.
Calcification of the lead coils can cause the device to fail or function improperly. This issue may lead to serious medical complications, including death or the need for emergency cardiac resuscitation.
Quantity affected: 247,702 in US; 344,670 outside US.
Permanent Defibrillator Electrodes.
Permanent Defibrillator Electrodes.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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