POLARx™ FIT M004CRBS2060Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08714729992622), received between Jan 12, 2024 and Jul 28, 2026 — classified as 7 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Body Fluid” (1 report).

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.

Recalls naming this device

1. 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-0300-2025 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced severe chest discomfort following a cryoablation procedure. On (B)(6) 2026, the patient underwent a cryoablation procedure using a PolarX Fit Balloon Catheter. The procedure was completed successfully. Subsequently, the patient began expressing severe chest discomfort and inability to exercise due to fatigue on (B)(6) 2026. An adjustment in oral medication was prescribed, and ECG diagnostic tests were performed. The patient was reported to be in stable condition with a resolution date of (B)(6) 2026.

  Patient problems: Chest Pain; Fatigue

  MAUDE report 50062988 ↗
• MalfunctionJan 28, 2026Unintended Deflation

  IT WAS REPORTED THAT THE BALLOON DEFLATED AUTOMATICALLY. DURING AN ABLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION, A POLARX FIT WAS USED IN THE LEFT SUPERIOR PULMONARY VEIN (LSPV). THE FIRST APPLICATION WAS UNEVENTFUL; HOWEVER, DURING THE SECOND APPLICATION, THE BALLOON WAS OBSERVED TO DEFLATE AUTOMATICALLY. THE SAME PROBLEM OCCURRED DURING TWO SUBSEQUENT ATTEMPTS, AND NO ERROR MESSAGES WERE DISPLAYED. A DIFFERENT DEVICE WAS THEN USED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT COMPLICATIONS. THE DEVICE WAS CONTAMINATED AND WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24202447 ↗
• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem

  CLINICAL STUDY POLARX PAS PY003; SUBJECT ID: (B)(6). PER CLINICAL REPORT, IT WAS REPORTED THAT POST PULMONARY VEIN ISOLATION (PVI) ABLATION PROCEDURE USING THE POLARXFIT CATHETER, THE PATIENT EXPERIENCED PERSISTENT COUGH. PATIENT REPORTED CHEST/LUNG IRRITATION AND COUGHING FREQUENTLY WHEN SHE BREATHES SINCE PROCEDURE. ORAL MEDICATION WAS CHANGED/ADJUSTED TO RESOLVE THE ISSUE. ALSO, A CHEST X-RAY WAS PERFORMED. EVENT RESOLVED ON (B)(6) 2025 AND PATIENT IS NOW RECOVERED. DEVICE IS NOT EXPECTED TO BE RETURNED AS IT WAS DISCARDED POST PROCEDURE.

  Patient problems: Cough

  MAUDE report 24146703 ↗
• InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION. DURING A PULMONARY VEIN ISOLATION (PVI) PROCEDURE TO TREAT ATRIAL FIBRILLATION, A POLARX CATHETER WAS SELECTED FOR USE. FOLLOWING TREATMENT OF ALL FOUR PULMONARY VEINS AND REMOVAL OF THE POLARX CATHETER, INTRACARDIAC ECHOCARDIOGRAPHY (ICE) WAS USED TO VISUALIZE THE PERICARDIUM. AN EFFUSION WAS NOTED. THIS EFFUSION WAS NOT APPARENT AT BASELINE. PROTAMINE WAS ADMINISTERED. THERE WERE NO CHANGES IN HEMODYNAMICS DURING THE CASE THAT WOULD INDICATE THE PRESENCE OF AN EFFUSION. THE EFFUSION WAS MONITORED FOR THE NEXT 30 MIN WITH ICE AND A TRANSTHORACIC ECHOCARDIOGRAM (TTE) WAS PERFORMED. THE EFFUSION WAS MOST NOTABLE AT THE BASAL ASPECT OF THE RIGHT VENTRICLE AND MEASURED APPROXIMATELY 2.1 CM AT ITS LARGEST POINT. DURING MONITORING, ULTRASOUND CONTRAST WAS ADMINISTERED INTRAVENOUSLY AND WAS ASSESSED TO SEE IF IT ENTERED THE PERICARDIAL SPACE. NO CONTRAST ENTERED THE PERICARDIAL SPACE. THE PATIENT'S HEMODYNAMICS WERE NOT ALTERED AT ALL DURING THIS PERIOD. THERE WAS LIMITED SPACE TO PERFORM A PERICARDIOCENTESIS AS THE EFFUSION SIZE WAS FAIRLY SMALL DURING DIASTOLE. IT WAS DECIDED THAT A PERICARDIOCENTESIS WOULD NOT BE PER

  Patient problems: Pericardial Effusion

  MAUDE report 22886494 ↗
• MalfunctionJul 23, 2025Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT THE BALLOON COULD NOT BE DEFLATED. DURING A POLARX CRYOABLATION PROCEDURE, A CATHETER WAS SELECTED FOR USE. ACCORDING TO THE CUSTOMER, THE CATHETER WAS PREPARED CORRECTLY, BUT THEY WERE UNABLE TO DEFLATE THE BALLOON, SO IT WAS REPLACED. MOST QUESTIONS COULD NOT BE ANSWERED BY THE CUSTOMER, AS THEY WANTED TO PROCEED QUICKLY WITH THE PROCEDURE AND SIMPLY STATED THAT THE BALLOON COULD NOT BE DEFLATED. THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT COMPLICATIONS. THE CATHETER CANNOT BE RETURNED BECAUSE, UNFORTUNATELY, THE CARE PROVIDER HAD ALREADY DISCARDED IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22579195 ↗
• InjuryApr 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT EXPERIENCED CARDIAC TAMPONADE. SUBSEQUENTLY, THE PROCEDURE WAS CANCELLED. DURING A CRYOABLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION, A POLARX FIT CATHETER WAS SELECTED FOR USE. AFTER PERFORMING A TRANSSEPTAL PUNCTURE USING THE VERSACROSS, THE POLARX FIT CATHETER WAS INSERTED, AND TREATMENT OF THE LEFT INFERIOR PULMONARY VEIN BEGAN. APPROXIMATELY 100 SECONDS INTO THE APPLICATION, THE PATIENT'S BLOOD PRESSURE DROPPED, AND A DOUBLE STOP WAS INITIATED ON THE CRYOABLATION SYSTEM. IT WAS NOTED THAT THE PATIENT HAD A SMALL PERICARDIAL EFFUSION/TAMPONADE. PERICARDIAL DRAINAGE WAS PERFORMED AND COMPLETED AT 8:52AM. THE PATIENT WAS GIVEN 40 OF PROTAMINE AT 8:53AM TO REVERSE THE HEPARIN. A TOTAL OF 100CC OF BLOOD WAS DRAWN OUT AND AT 9:48AM, THE DRAIN STILL HAD NO BLOOD ACCUMULATION. ANESTHESIA WAS ABLE TO KEEP THE PATIENT STABLE THROUGHOUT WITH LITTLE MANAGEMENT AND ONLY 1 SHOT OF EPINEPHRIN WAS GIVEN. THE PROCEDURE WAS CANCELLED AT THIS TIME. THE PATIENT LEFT THE ROOM AT 9:50AM AND WAS TAKEN TO THE ICU. THE PATIENT WAS ALERT AND DOING WELL POST PROCEDURE. PATIENT WAS TO REMAIN IN HOSPITAL FOR 2-3 DAYS TO BE MONITORED BUT WAS EXPECTED TO MAKE A FULL RECOVERY. IT

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension

  MAUDE report 21890282 ↗
• InjuryJan 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL STUDY (B)(6) FOR POLARX PAS; SUBJECT ID # (B)(6). IT WAS REPORTED THAT POST PROCEDURE, THE PATIENT EXPERIENCED NAUSEA, HYPOTENSION AND WAS SUBSEQUENTLY DIAGNOSED WITH CARDIAC TAMPONADE AND PERICARDIAL EFFUSION, WHICH REQUIRED SURGICAL INTERVENTION. DURING A PULMONARY VEIN ISOLATION CRYOABLATION PROCEDURE, A POLARX FIT CATHETER WAS SELECTED FOR USE. POST TREATMENT, THE PATIENT EXPERIENCED EPISODES OF NAUSEA AND HYPOTENSION. AN URGENT ECHOCARDIOGRAM AND ULTRASOUND WERE PERFORMED AND SHOWED A MODERATE-SIZED PERICARDIAL EFFUSION, 1.8CM AT MAX. THIS EFFUSION CAUSED CARDIAC TAMPONADE. THE PATIENT WAS TAKEN TO THE CATH LAB WHERE A PERICARDIOCENTESIS WAS PERFORMED AND 275CC OF SANGUINOUS DRAINAGE WAS REMOVED. THIS EVENT RESULTED IN IN-PATIENT HOSPITALIZATION OR PROLONGATION OF EXISTING HOSPITALIZATION. THE PATIENT WAS DISCHARGED ON (B)(6) 2025, IMAGING PERFORMED (ULTRASOUND) SHOWED THAT THE ISSUE HAD RESOLVED. THE DEVICE WAS DISPOSED BY THE FACILITY AND WILL NOT BE RETURNED AS THE DEVICE PERFORMED AS EXPECTED DURING THE PROCEDURE AND THERE WERE NO REPORTS OF ANY PERFORMANCE CONCERNS.

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension; Nausea; Pericardial Effusion

  MAUDE report 21267199 ↗
• MalfunctionDec 30, 2024Device Contamination with Body Fluid; Device Contamination with Body Fluid

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED POST PATIENT SEDATION. DURING FIBRILLATION PROCEDURE TO TREAT PATIENT WITH FIBRILLATION, A POLARX FIT WAS SELECTED FOR USE. IT WAS OBSERVED THAT THE PHYSICIAN USED THE POLARX FIT FOR CRYOABLATION AT THE LEFT SUPERIOR PULMONARY VEIN AND THE TEMPERATURE DROPPED TO MINUS 70 DEGREES. AN ERROR FOR DETECTED BLOOD IN THE BALLOON OCCURRED. THE PHYSICIAN TERMINATED OF THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21039607 ↗
• InjuryDec 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POLARX PAS CLINICAL STUDY. IT WAS REPORTED THAT A PERFORATION, PERICARDIAL EFFUSION AND CARDIAC TAMPONADE OCCURRED. A POLARX FIT ABLATION CATHETER AND INTELLAMAP ORION DIAGNOSTIC CATHETER WAS SELECTED FOR ABLATION TREATMENT TO THE LEFT INFERIOR PULMONARY VEIN. IT WAS NOTED THAT THE SYSTOLIC BLOOD PRESSURE WAS 70S. IT WAS SUSPECTED THAT THE INTELLAMAP ORION PERFORATED THE LEFT ARTRIA DURING INITIAL MAPPING. THEREFORE, EXAMINATION OF INTRACARDIAC ULTRASOUND WAS PERFORMED WHICH THEN REVEALED A 1CM EFFUSION. GIVEN THE NEW EFFUSION, PROCEDURE WAS TERMINATED AND LEFT FEMORAL ARTERIAL LINE WAS OBTAINED AS PERICARDIOCENTESIS WAS PERFORMED. CHEST WAS PREPPED AND DRAPED IN USUAL STERILE FASHION AND ULTRASOUND GUIDANCE WAS USED WHICH NOTED SUBXIPHOID DISTANCE TO THE PERICARDIUM WAS CLOSER TO 8 TO 0CM. LEFT PARASTERNAL ULTRASOUND VIEW WAS MUCH BETTER AND ONLY 4CM AWAY AND THEREFORE WAS USED FOR ACCESS WITHOUT DIFFICULTIES. WIRE IN THE PERICARDIUM CIRCUMSCRIBING THE CARDIAC SHADOW WAS CONFIRMED ON FLUOROSCOPY. A TOTAL OF 450CC OF BRIGHT BLOOD WAS REMOVED FROM THE PERICARDIUM WITHOUT DIFFICULTY AND BLOOD PRESSURE RESUMED AND ULTRASOUND CONFIRMED COMPLETE RESOLUTION OF THE PERICARDIAL EFFUSION. D

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Pericardial Effusion

  MAUDE report 20957137 ↗
• InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL STUDY (B)(6) FOR POLARX PAS; SUBJECT ID (B)(6). IT WAS REPORTED THAT POST PROCEDURE, THE PATIENT EXPERIENCED PERICARDITIS REQUIRING MEDICAL TREATMENT. DURING A THREE (3) MONTH FOLLOW-UP POST ABLATION PROCEDURE WITH A POLARX CATHETER, THE PATIENT NOTIFIED THE PHYSICIAN THAT A FEW HOURS AFTER DISCHARGE, THEY EXPERIENCED PERICARDITIS AND RECURRENCE OF ATRIAL FIBRILLATION. THE PATIENT WAS TREATED AT AN OUTSIDE FACILITY WHERE THEY UNDERWENT SURGERY AND WERE PRESCRIBED ORAL MEDICATION; COLCHICINE, FLECAINIDE AND DILTIAZEM. THE PATIENT CONDITION HAS RESOLVED. A REQUEST FOR THE MEDICAL RECORDS WAS SENT, UPDATES PENDING ONCE THOSE RECORDS ARE RECEIVED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THE DEVICE WAS DISPOSED BY THE FACILITY AND WILL NOT BE RETURNED AS THE DEVICE PERFORMED AS EXPECTED DURING THE PROCEDURE AND THERE WERE NO REPORTS OF ANY PERFORMANCE CONCERNS. IT WAS FURTHER REPORTED PER ADDITIONAL INFORMATION THAT THE PATIENT UNDERWENT AN ABLATION PROCEDURE ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT AT (B)(6) WITH CHIEF COMPLAINTS OF CHEST PAIN AND SHORTNESS OF BREATH, JUST A FEW HOURS AFTER BEING DISCHARGED FROM BANNER HEALTH

  Patient problems: Atrial Fibrillation; Pericarditis

  MAUDE report 20902632 ↗
• MalfunctionApr 1, 2024

  CRYO BALLOON BLOOD DETECTION ERROR /CATHETER REMOVED. NEW CATHETER OPENED. NO HARM TO PATIENT. PROBLEM RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19010765 ↗
• MalfunctionJan 18, 2024

  BLOOD DETECTED IN BALLOON CATHETER - ALERT GIVEN ON CONSOLE DURING CASE, WHILE CATHETER WAS IN BODY. CATHETER REMOVED, REPLACED WITH A NEW ONE. NO PATIENT HARM. DOCTOR WAS PRESENT. MANUFACTURER REPRESENTATIVE CALLED INTO HIS COMPANY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18534035 ↗
• MalfunctionJan 12, 2024

  CRYO BALLOON CATHETER IN USE DURING ABLATION. THE BOSTON SCIENTIFIC POLARX CRYO MACHINE READ: ¿REFRIGERANT FLOW OBSTRUCTION DETECTED¿ MANUFACTURER REP. STATED WE NEEDED TO SWITCH THE CATHETER, SO CATHETER THAT WAS IN THE BODY WAS REMOVED, PLACED IN BIOHAZARD BAG, LABEL WAS CUT OFF FROM PACKAGING AND ATTACHED TO BAG. MEDWATCH REPORT FILLED OUT. NEW CATHETER PLACED AND THERE WERE NOT ANYMORE ERRORS FOR THE REST OF THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18502156 ↗

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-0301-2025 · Oct 10, 2024 · Open, Classified
  Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110
• Z-0299-2025 · Oct 10, 2024 · Open, Classified
  Boston Scientific POLARx FIT BALLOON CATHETER ST OUS, Material Number M004CRBS2010
• Z-0298-2025 · Oct 10, 2024 · Open, Classified
  Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100
• Z-0302-2025 · Oct 10, 2024 · Open, Classified
  Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS2160
• Z-0297-2025 · Oct 10, 2024 · Open, Classified
  Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000.
• Z-0303-2025 · Oct 10, 2024 · Open, Classified
  Boston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004CRBS4000; CONSOLE REFURB: Material Number M004CRBS400R0; CONSOLE HOSPITAL, Material Number M004CRBS400H