Boston Scientific POLARx Balloon Catheter (Boston Scientific) – Use Instructions (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000.
Brand
Boston Scientific Corporation
Lot Codes / Batch Numbers
GTIN 08714729992561
Products Sold
GTIN 08714729992561
Boston Scientific Corporation is recalling Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000. due to Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistu. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026