Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS recall
Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100
Why was Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS recalled?
Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
GTIN 08714729992660
- Product
- Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 20290 units
- Distribution
- Worldwide
- Recall date
- November 20, 2024
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)