Boston Scientific recalls SMARTFREEZE CRYO CONSOLE units with specific material numbers due to updated instructions for atrio-esophageal fistula risk with POLARx and POLARx FIT Cryoablation Balloon Catheters.
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 updating instructions for their SMARTFREEZE CRYO CONSOLE devices to address a potential risk of atrio-esophageal fistula when used with POLARx and POLARx FIT Cryoablation Balloon Catheters. This recall focuses on specific model numbers and does not require immediate discontinuation of use.
The recall involves updated instructions for use related to a potential risk of atrio-esophageal fistula, which is an abnormal connection between the heart and esophagus. This risk occurs when the console is used with specific catheters during medical procedures.
Medical professionals using Boston Scientific SMARTFREEZE CRYO CONSOLE devices with POLARx and POLARx FIT Cryoablation Balloon Catheters are likely affected. Patients undergoing procedures with these devices may be at risk if the console is not updated properly.
Check for material numbers M004CRBS4000, M004CRBS400R0, M004CRBS400H0, or M004CRBS400Z0 on the console. The product was sold with GTIN 08714729992691.
Check the console for specific material numbers and review the updated instructions for safe use with POLARx and POLARx FIT Cryoablation Balloon Catheters.
No, the recall does not require immediate discontinuation of use. Updated instructions are provided for safe operation.
Affected consoles have material numbers M004CRBS4000, M004CRBS400R0, M004CRBS400H0, or M004CRBS400Z0.
The recall addresses a potential risk of atrio-esophageal fistula, but the hazard level is low risk as per the official notice.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0303-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0303-2025 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
