SMARTFREEZE recallZ-0303-2025 · Boston Scientific Corporation · initiated Oct 10, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-0303-2025
- Status
- Open, Classified
- Initiated by the company
- Oct 10, 2024
- Posted by the FDA
- Nov 12, 2024
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 1035 units
- Product code
- OAE
- FDA submissions
- P220032
- Distribution
- Worldwide
Product description
Boston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004CRBS4000; CONSOLE REFURB: Material Number M004CRBS400R0; CONSOLE HOSPITAL, Material Number M004CRBS400H0, CONSOLE ZERO, Material Number M004CRBS400Z0
Code information (models, lots, serial numbers)
GTIN 08714729992691
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- SMARTFREEZE™ M004CRBS4000Boston Scientific Corporation · Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation1 recall33 reports
Product lines
Other devices under the same FDA submission
4 devices cleared under P220032 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- POLARx™ FIT M004CRBS2060Boston Scientific Corporation · Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation1 recall13 reports
- POLARx™ FIT M004CRBS2160Boston Scientific Corporation · Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation1 recall1 report
- SMARTFREEZE™ M004CRBS400R0Boston Scientific Corporation · Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation2 reports
- SMARTFREEZE™ M004CRBS400Z0Boston Scientific Corporation · Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 95514).
- Z-0297-2025 · Open, ClassifiedBoston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000.
- Z-0298-2025 · Open, ClassifiedBoston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100
- Z-0299-2025 · Open, ClassifiedBoston Scientific POLARx FIT BALLOON CATHETER ST OUS, Material Number M004CRBS2010
- Z-0300-2025 · Open, ClassifiedBoston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060
- Z-0301-2025 · Open, ClassifiedBoston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110
- Z-0302-2025 · Open, ClassifiedBoston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS2160
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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