POLARx™ FIT M004CRBS2160Recalls & reported problems
Boston Scientific Corporation · Cryoablation Balloon Catheter · Class 3
All models of POLARx FIT (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00191506016463), received between Nov 13, 2025 and Nov 13, 2025 — classified as 1 injury.
1 FDA recall record name this device's identifier, 1 still open.
6 other recalls cover devices cleared under the same FDA submission (P220032); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Oct 10, 2024Class IOpen, Classified
Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
Z-0302-2025 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Atrial Fibrillation1
- Chest Pain1
- Discomfort1
- Fatigue1
- Nausea1
- Pulmonary Embolism1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PER CLINICAL STUDY: POLARX PAS PY003 IT WAS REPORTED THAT A POLARX FIT CATHETER WAS SELECTED FOR USE. POST PROCEDURE, ON (B)(6) 2025, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH COMPLAINTS OF CHEST PAIN WORSENED BY DEEP INHALATION, ALONG WITH NAUSEA, FATIGUE, AND MALAISE. COMPUTED TOMOGRAPHY IMAGING CONFIRMED A LEFT UPPER LOBE PULMONARY EMBOLISM. THE PATIENT WAS ADMITTED TO TELEMETRY AND STARTED ON HEPARIN THERAPY. A VENOUS DUPLEX STUDY WAS NEGATIVE FOR DEEP VEIN THROMBOSIS. LABORATORY TESTS WERE ALSO PERFORMED. DURING ADMISSION, THE PATIENT EXPERIENCED AN EPISODE OF ATRIAL FIBRILLATION. IN THE CARDIOLOGIST'S NOTE DATED (B)(6) 2025, IT WAS STATED: "CONTINUED PAROXYSMS OF ATRIAL FIBRILLATION CAN BE SEEN IN THE IMMEDIATE PERIOD FOLLOWING AF ABLATION." THE PATIENT WAS STARTED ON MULTAQ AND SUBSEQUENTLY DISCHARGED ON THE SAME DAY WITH THIS MEDICATION. DEVICE IS NOT EXPECTED TO BE RETURNED AS COMPLICATIONS OCCURRED POST PROCEDURE, AFTER THE DEVICE WAS DISCARDED.
Patient problems: Atrial Fibrillation; Chest Pain; Discomfort; Fatigue; Nausea; Pulmonary Embolism
MAUDE report 23549907 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P220032. One submission often covers many models, so check the product and lot details in each record.
- Z-0299-2025 · Oct 10, 2024 · Open, ClassifiedBoston Scientific POLARx FIT BALLOON CATHETER ST OUS, Material Number M004CRBS2010
- Z-0300-2025 · Oct 10, 2024 · Open, ClassifiedBoston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060
- Z-0303-2025 · Oct 10, 2024 · Open, ClassifiedBoston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004CRBS4000; CONSOLE REFURB: Material Number M004CRBS400R0; CONSOLE HOSPITAL, Material Number M004CRBS400H
- Z-0297-2025 · Oct 10, 2024 · Open, ClassifiedBoston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000.
- Z-0298-2025 · Oct 10, 2024 · Open, ClassifiedBoston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100
- Z-0301-2025 · Oct 10, 2024 · Open, ClassifiedBoston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110
Other Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation devices
- TactiCath™ A-TCSE-DFSt. Jude Medical, Inc. · Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation1 recall23 deaths923 reports
- TactiCath™ PN-004075St. Jude Medical, Inc. · Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation7 deaths338 reports
- TactiFlex™ Sensor Enabled™ A-TFSE-DFSt. Jude Medical, Inc. · Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation1 recall6 deaths241 reports
- TactiCath™ A-TCSE-FJSt. Jude Medical, Inc. · Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation1 recall3 deaths174 reports
- Sphere-9™ Catheter AFR-00001Medtronic, Inc. · Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation1 recall3 deaths147 reports
- TactiCath™ A-TCSE-DSt. Jude Medical, Inc. · Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation2 deaths175 reports
- TactiSys™ PN-004400St. Jude Medical, Inc. · Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation1 recall125 reports
- QDOT MICRO D139402Biosense Webster Inc · Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation3 deaths171 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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