Boston Scientific recalls POLARx FIT Balloon Catheters (Material Number M004CRBS2:2010) due to potential atrio-esophageal fistula risk. Affected patients should contact for guidance.
Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
Boston Scientific is recalling POLARx FIT Balloon Catheters because they may cause an atrio-esophageal fistula, a connection between the heart and esophagus. This risk is serious and requires immediate attention from patients using the device.
The catheter may create an abnormal connection between the heart and esophagus during procedures, leading to serious complications. This risk occurs when the catheter is used improperly or in specific anatomical conditions.
Patients using the recalled POLARx FIT Balloon Catheter (Material Number M004CRBS2010) are affected. Those with heart conditions or undergoing cardiac procedures are at higher risk.
Check for the Material Number M004CRBS2010 on the catheter packaging or device. The product was sold with the GTIN 08714729992578.
Immediately discontinue use of the recalled POLARx FIT Balloon Catheter (Material Number M004CRBS2010) if you have it.
The catheter may cause an atrio-esophageal fistula, a connection between the heart and esophagus, which can lead to serious complications.
Look for the Material Number M004CRBS2010 on the catheter packaging or device. The product was sold with the GTIN 08714729992578.
Immediately stop using it and contact Boston Scientific for guidance on next steps.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0299-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0299-2025 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
