Boston Scientific Corporation is recalling 445 units of the FARAWAVE 1.0 Pulsed Field Ablation Catheter (Product ID M004PF41M401). The potentially impacted units were manufactured using specific equipment that may have caused cracks in the electrode bands on the catheter's distal end. No incidents or injuries have been reported at this time.
Cracks in the electrode bands at the distal end of the catheter could lead to device failure or cause potential injury to a patient's cardiac or vascular structures during a medical procedure.
Recall #: Z-2278-2025
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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