Boston Scientific is recalling 35,739 units of POLARx and POLARx FIT Cryoablation Balloon Catheters and SMARTFREEZE CRYO CONSOLES to update safety instructions for medical professionals. The recall addresses the risk of Atrio-esophageal Fistula, a dangerous connection between the heart and the esophagus that can occur during cardiac procedures. No injuries have been reported in the provided data.
The use of these catheters in cryoablation procedures carries a risk of creating an abnormal opening between the heart's left atrium and the esophagus. This serious complication can lead to severe infections, stroke, or death if the procedure is not performed according to the newly updated safety guidelines.
Recall #: Z-0297-2025; Quantity: 4422 units
Recall #: Z-0298-2025; Quantity: 20290 units
Recall #: Z-0299-2025; Quantity: 5913 units
Recall #: Z-0300-2025; Quantity: 960 units
Recall #: Z-0301-2025; Quantity: 2751 units
Recall #: Z-0302-2025; Quantity: 368 units
Recall #: Z-0303-2025; Quantity: 1035 units
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
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.