Boston Scientific recalls POLARx Balloon Catheters due to potential atrio-esophageal fistula risk. Learn if your device is affected and 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 POLAR: Balloon catheters that could pose a risk of creating an abnormal connection between the heart and esophagus during medical procedures. This recall is due to a potential risk of a serious complication that could require surgery.
The catheter may create an abnormal connection between the heart and esophagus during medical procedures. This can lead to serious complications requiring surgery if not properly managed.
Medical professionals using the POLARx Balloon Catheter LT 28MM OUS for procedures. Patients undergoing cardiac ablation procedures are at risk if the catheter is used incorrectly.
Check for the POLARx Balloon Catheter LT 28MM OUS with Material Number M004CRBS2100. The product was sold with GTIN 08714729992660.
Boston Scientific has updated the instructions for use to address the atrio-esophageal fistula risk.
This recall is for medical professionals using the catheter during procedures. Patients are at risk if the catheter is used incorrectly.
The catheter may create an abnormal connection between the heart and esophagus during medical procedures, which could require surgery.
Check for the POLARx Balloon Catheter LT 28MM OUS with Material Number M004CRBS2100 or GTIN 08714729992660.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0298-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0298-2025 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.
