Boston Scientific Cryoablation Balloon Catheters Instruction Update for Fistula Risk
Boston Scientific is updating safety instructions for POLARx cryoablation balloon catheters due to atrio-esophageal fistula risk. The update affects approximately 2,751 units distributed worldwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which establishes a minimum severity score of 4. While atrio-esophageal fistula is a serious, potentially fatal complication of cardiac procedures, the source text does not report any actual cases of illness, injury, or death, therefore the classification remains at Severe rather than Critical.
Plain-English summary
Boston Scientific Corporation is updating the instructions for use of POLARx and POLARx FIT Cryoablation Balloon Catheters (Material Number M004CRBS2110, GTIN 00191506016456). This action affects approximately 2,751 units that have been distributed worldwide.
The update addresses the risk of atrio-esophageal fistula, a serious complication that can occur during or after cryoablation procedures using these catheters. Atrio-esophageal fistula is an abnormal connection that may develop between the heart's atrium and the esophagus.
Healthcare providers and facilities using these catheters are affected by this safety update. This is classified as an FDA Class I recall.
Affected users should review the updated instructions for use from Boston Scientific Corporation to understand the associated risks and any recommended precautions or modifications to procedural techniques.
The recalled product
- Product
- Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 2,751
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- GTIN00191506016456
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 7 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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