Recall Z-0302-2025
Boston Scientific Corporation · initiated October 10, 2024
Class I – dangerous or defective products that could cause serious health problems or death
Product
Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS2160
Codes / lots: GTIN 00191506016463
Reason for recall
Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
FDA-determined cause: Device Design
Action taken
Boston Scientific disseminated a letter to Physicians/Healthcare Professionals on 10/10/2024 via courier. The letter notified its consignees of updates to the instructions for use (IFU) for the POLARx and POLARx FIT Cryoablation Catheter related to the risk of atrioesophageal (AE) fistula. The firm requested that the information be shared with clinicians who use the use the Boston Scientific POLARx Cryoablation System, including the POLARx Catheter, the POLARx FIT Catheter and the SMARTFREEZE Console, and to share the communication with any other organization to which these devices may have been transferred. Users were directed to immediately post the information on or near the product to ensure this information is easily accessible to all users of the device.
Details
- Recall number
- Z-0302-2025
- Initiated
- October 10, 2024
- Posted by FDA
- November 12, 2024
- Product code
- OAE – Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
- Quantity
- 368 units
- Distribution
- Worldwide
- Recalling firm
- Boston Scientific Corporation, Saint Paul, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0297-2025 Class I | Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000.Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon… | 10/10/2024Open, Classified |
| Z-0298-2025 Class I | Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon… | 10/10/2024Open, Classified |
| Z-0299-2025 Class I | Boston Scientific POLARx FIT BALLOON CATHETER ST OUS, Material Number M004CRBS2010Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon… | 10/10/2024Open, Classified |
| Z-0300-2025 Class I | Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon… | 10/10/2024Open, Classified |
| Z-0301-2025 Class I | Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon… | 10/10/2024Open, Classified |
| Z-0303-2025 Class I | Boston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004CRBS4000…Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon… | 10/10/2024Open, Classified |