Boston Scientific recalls POLARx balloon catheters ST 28MM OUS (Material M004CRBS2000) due to potential atrio-esophageal fistula risk. Learn what to do.
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 their POLARx balloon catheters ST 28MM OUS (Material Number M004CRBS2000) because of a risk of atrio-esophageal fistula. This is a serious medical complication that could occur during procedures.
The catheter design may cause an abnormal connection between the heart and esophagus during procedures. This can lead to serious complications like bleeding or infection if not properly managed.
Patients undergoing cardiac procedures who use this specific balloon catheter model are affected. Medical professionals performing procedures with this catheter are at highest risk.
Check for the model name 'POLARx BALLOON CATHETER ST 28MM OUS' and material number M004CRBS2000 on the device. This product was sold with GTIN 08714729992561.
Look for the model name 'POLARx BALLOON CATHETER ST 28MM OUS' and material number M004CRBS2000 on the device.
The recall states there is a risk of atrio-esophageal fistula, so it is not safe to use without following the updated instructions.
The recall does not specify a remedy, so contact Boston Scientific directly for guidance.
Check for the model name 'POLARx BALLOON CATHETER ST 28MM OUS' and material number M004CRBS2000 on the device.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0297-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0297-2025 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.
