Z-0301-2025Class I

Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110

Name: Z-0301-2025 Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110
Creator: Boston Scientific Corporation
Published: 2024-10-10
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2024-10-10 / Open, Classified / root cause: design

FDA source

Boston Scientific Corporation began a recall of Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110 on 2024-10-10. FDA classified it as Class I and gives the reason as "Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0301-2025
Classification: Class I
Status: Open, Classified
Initiated: 2024-10-10
Posted: 2024-11-12
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110
Product code: OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
Reason for recall: 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 tag: design
FDA 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 in commerce: 2751 units
Distribution: Worldwide
Product codes and lots: GTIN00191506016456

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0301-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0297-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-11-20	2024-11-12
Z-0298-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-11-20	2024-11-12
Z-0299-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-11-20	2024-11-12
Z-0300-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-11-20	2024-11-12
Z-0301-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-11-20	2024-11-12
Z-0302-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-11-20	2024-11-12
Z-0303-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-11-20	2024-11-12

Product code OAE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)