Boston Scientific recalls POLARx FIT Balloon Catheters due to potential atrio-esophageal fistula risk. Learn what to do if you own this device.
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 the heart and esophagus). This is a serious risk that could lead to complications requiring surgery.
The catheter may create an abnormal connection between the heart and esophagus during procedures. This can cause serious complications like bleeding, infection, or the need for surgery.
Patients who have received this specific balloon catheter for cardiac procedures are most at risk. Healthcare providers using the device for procedures are also affected.
Check for the model name 'POLARx FIT BALLOON CATHETER LT OUS' with material number M004CRBS2110. The device was sold with GTIN 00191506016456.
Identify the model name and material number to confirm if your device is recalled.
Reach out to Boston Scientific for guidance on next steps if you have the recalled device.
This recall affects patients who received the device and healthcare providers using it for procedures.
The catheter may cause an atrio-esophageal fistula, which is an abnormal connection between the heart and esophagus that can lead to serious complications.
Check for the model name 'POLARx FIT BALLOON CATHETER LT OUS' with material number M004CRBS2110 or GTIN 00191506016456.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0301-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0301-2025 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.
