Boston Scientific Corporation is recalling approximately 1,404,232 pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps), including the ACCOLADE, ESSENTIO, PROPONENT, VALITUDE, and VISIONIST families. The recall was initiated to provide a critical software maintenance release (SMR6) for devices that may require updates to maintain proper function. These implantable devices are primarily used to treat heart conduction disorders and congestive heart failure secondary to a slow heart rate.
The software update is required to ensure the continued reliability and performance of the pacemakers. While no injuries have been reported, failure to apply the software update could potentially impact the device's ability to manage heart rhythm effectively.
Includes ESSENTIO, PROPONENT, ACCOLADE, and ALTRUA 2 families. All serialized DR-EL pacemakers from the ACCOLADE family are included. Use the manufacturer lookup tool for precise identification.
Includes VALITUDE and VISIONIST families. All serialized CRT-Ps from the ACCOLADE family are included.
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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