Boston Scientific SMARTFREEZE CRYO CONSOLE: Console recall
Boston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004CRBS4000; CONSOLE REFURB: Material Number M004CRBS400R0; CONSOLE HOSPITAL…
Why was Boston Scientific SMARTFREEZE CRYO CONSOLE: Console 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 08714729992691
- Product
- Boston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004CRBS4000; CONSOLE REFURB: Material Number M004CRBS400R0; CONSOLE HOSPITAL…
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 1035 units
- Distribution
- Worldwide
- Recall date
- November 20, 2024
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)