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). This is a serious risk that could lead to complications requiring surgery.
The catheter design could create an abnormal connection between the heart and esophagus during procedures. This risk is higher when the catheter is used in certain cardiac ablation treatments.
Patients undergoing cardiac ablation procedures who use the recalled catheters are most at risk. Healthcare providers using these devices for treatment may also be affected.
Check for the model name 'POLARx FIT Balloon Catheter LT US' with material number M004CRBS2160. The product was sold in the US with GTIN 00191506016463.
Boston Scientific has updated the instructions for use to address the atrio-esophageal fistula risk. Follow the new guidelines to ensure safe procedures.
Yes, the recall addresses a potential risk of an atrio-esophageal fistula, which is an abnormal connection between the heart and esophagus that could require surgery.
Boston Scientific has updated the instructions for use. Patients and healthcare providers should follow the new guidelines to reduce the risk of complications.
Look for the model name 'POLARx FIT Balloon Catheter LT US' with material number M004CRBS2160. The product was sold in the US with GTIN 00191506016463.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0302-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0302-2025 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.
