Boston Scientific recalls POLARx FIT Balloon Catheters due to potential atrio-esophageal fistula risk. Learn about affected models and safety steps.
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 (an abnormal connection between heart and esophagus) during procedures. This risk is serious and requires immediate attention from medical users.
The catheter design may create an abnormal connection between the heart and esophagus during procedures. This can lead to serious complications like bleeding, infection, or organ damage if not properly managed.
Medical professionals using Boston Scientific POLARx FIT Balloon Catheters for procedures are affected. Patients undergoing these procedures are at risk of life-threatening complications.
Check for the model name 'POLARx FIT Balloon Catheter ST US' with material number M004CRBS2060. The product was sold in the U.S. with GTIN 08714729992622.
Immediately stop using the recalled POLARx FIT Balloon Catheter ST US model if you have it.
The catheter may cause an atrio-esophageal fistula, which is an abnormal connection between the heart and esophagus that can lead to serious complications like bleeding or infection.
Check for the model name 'POLARx FIT Balloon Catheter ST US' with material number M004CRBS2060 or GTIN 08714729992622.
Immediately stop using it and contact Boston Scientific for further instructions.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0300-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0300-2025 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.
