FDA Updates POLARx Cryoablation Catheter Instructions for Atrio-esophageal Fistula Risk
Boston Scientific is updating instructions for POLARx and POLARx FIT cryoablation catheters to address atrio-esophageal fistula risks. The FDA classified this as a Class I recall affecting approximately 20,290 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: FDA Class I classification requires a minimum severity score of 4. Although no reported illnesses or injuries are documented in the recall notice, the hazard—atrio-esophageal fistula—is a serious, potentially life-threatening complication.
Plain-English summary
Boston Scientific Corporation is updating the instructions for use of its POLARx and POLARx FIT Cryoablation Balloon Catheters to address risks related to atrio-esophageal fistula formation. No reported cases of patient harm are mentioned in the recall notice.
Atrio-esophageal fistula is a serious complication that can occur during cryoablation procedures performed in proximity to the esophagus. The manufacturer is revising instructions to help mitigate this risk.
The FDA classified this as a Class I recall affecting approximately 20,290 units with worldwide distribution. Healthcare providers using these devices should obtain and review the updated instructions from Boston Scientific. Patients who have been treated with these catheters should consult their healthcare provider with any concerns.
The recalled product
- Product
- Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 20,290
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 08714729992660
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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