Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000.
Recall
- Recall Number
- Z-0297-2025
- Event Number
- 95514
- Firm
- Boston Scientific Corporation
- FEI Number
- 2124215
- Product Code
- OAE
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- October 10, 2024
- Posted
- November 12, 2024
- Address
- 4100 Hamline Ave N, Saint Paul, MN, 55112-5700
Description
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 Catheters related to Atrio-esophageal Fistula Risk.
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.
Worldwide
4422 units