Boston Scientific Cryoablation Balloon Catheters Recalled for Fistula Risk
Boston Scientific is updating instructions for POLARx and POLARx FIT cryoablation balloon catheters due to atrio-esophageal fistula risk. Affected devices were 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 mandates a minimum severity of Severe. Although no reported illnesses or injuries are documented in this recall notice, the atrio-esophageal fistula risk represents a serious, known complication of ablation procedures.
Plain-English summary
Boston Scientific Corporation has issued a Class I recall of its POLARx and POLARx FIT cryoablation balloon catheters (Material Number M004CRBS2160, GTIN 00191506016463). The recall affects 368 units that were distributed worldwide. The company is updating the instructions for use related to atrio-esophageal fistula risk—a serious complication that can occur during cardiac ablation procedures.
Atrio-esophageal fistula is an abnormal opening between the heart and esophagus that can develop during ablation therapy. This complication can have serious medical consequences. The updated instructions are intended to help healthcare providers better manage this known risk.
Patients who have received treatment with the affected catheters should consult their healthcare provider with any questions about this recall. Healthcare facilities should review the updated instructions and implement them in their clinical practices.
The recalled product
- Product
- Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS2160
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 368
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 00191506016463
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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