Boston Scientific POLARx Cryoablation Catheters Instructions Updated for Fistula Risk
Boston Scientific is updating instructions for POLARx and POLARx FIT cryoablation catheters to address atrio-esophageal fistula risk, a potentially serious complication from ablation procedures. FDA Class I recall affecting 4422 units 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. No reported illnesses or deaths are documented in the source; the hazard is a documented risk requiring an update to instructions for use.
Plain-English summary
Boston Scientific is updating the instructions for use of POLARx and POLARx FIT cryoablation balloon catheters due to a risk of atrio-esophageal fistula. This is a potentially serious complication where an abnormal connection may form between the heart's atrium and the esophagus during cardiac ablation procedures.
The specific product listed includes material number M004CRBS2000 (GTIN 08714729992561), with 4422 units distributed worldwide. This is an FDA Class I recall.
Healthcare providers using these devices should review the updated instructions for use to understand the fistula risk and proper precautions. Patients and healthcare professionals should consult with their care team regarding the appropriate use of these devices in clinical settings.
The recalled product
- Product
- Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000.
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 4,422
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)
- GTIN 08714729992561
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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