FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100
- Recall number
- Z-0298-2025
- Recalling firm
- Boston Scientific Corporation
- Product
- Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100
- Status
- Open, Classified
- Initiated
- 2024-10-10
- Posted
- 2024-11-12
- Terminated
- not on file
- Reason
- Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
- Root cause
- Device Design
- Action
- 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.
- Quantity
- 20290 units
- Distribution
- Worldwide
- Lot, serial or model codes
- GTIN 08714729992660
- 510(k) numbers
- not on file
- PMA numbers
- ["P220032"]
- Product code
- OAE
- Firm FEI
- 2124215
- Firm city
- Saint Paul
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28