—#210468

Product

Boston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004CRBS4000; CONSOLE REFURB: Material Number M004CRBS400R0; CONSOLE HOSPITAL, Material Number M004CRBS400H0, CONSOLE ZERO, Material Number M004CRBS400Z0

FDA product code: OAE — Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P220032
Affected lot / code info: GTIN 08714729992691

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Boston Scientific Corporation
Address: 4100 Hamline Ave N, Saint Paul, Minnesota 55112-5700

Distribution

Distribution pattern: Worldwide

Timeline

Recall initiated: 2024-10-10
Posted by FDA: 2024-11-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #210468. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.