SMARTFREEZERecalls & reported problems across all models

We found 3 models of SMARTFREEZE by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 36 adverse event reports in the FDA's MAUDE database, received between Aug 28, 2023 and Dec 22, 2025 — classified as 1 injury, 35 malfunctions.

The most frequently reported specific device problem is “Increase in Pressure” (14 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

SMARTFREEZE recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Oct 10, 2024Open, 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-0303-2025 · Root cause: Device Design · Recall details · FDA record ↗

Most reported SMARTFREEZE problems

SMARTFREEZE models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• SMARTFREEZE™ M004CRBS4000

  Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
  1 recall33 reports
• SMARTFREEZE™ M004CRBS400R0

  Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
  2 reports
• SMARTFREEZE™ M004CRBS400Z0

  Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
  1 report

Recent SMARTFREEZE adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2025Increase in Pressure; Increase in Pressure

  IT WAS REPORTED THAT "ERROR 1-00000020-2 OUTER BALLOON PRESSURE (OBP) TOO HIGH" OCCURRED. SUBSEQUENTLY, THE PROCEDURE WAS CANCELLED. A SMARTFREEZE CRYOABLATION CONSOLE WAS SELECTED FOR USE. THE ERROR MESSAGE "THE OUTER BALLOON PRESSURE TOO HIGH" APPEARED. TROUBLESHOOTING WAS PERFORMED BUT WAS UNABLE TO RESOLVE THE ISSUE. SUBSEQUENTLY, THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER DETAILS WERE PROVIDED TO EXPLAIN WHEN THE ISSUE OCCURRED OR IF THE PATIENT WAS SEDATED PRIOR TO THIS CANCELLATION. FIELD SERVICE WAS PROVIDED TO THE DEVICE, BUT NO TECHNICAL ISSUES WERE IDENTIFIED. GOOD FAITH EFFORTS (GFE) HAS BEEN SENT TO IDENTIFY IF THE DEVICE WILL BE RETURNED FOR ANALYSIS. THIS IS BEING REPORTED FOR PROCEDURE CANCELLATION WITH SEDATION STATUS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23865614 ↗
• MalfunctionNov 12, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE CONSOLE WAS UNABLE TO RECOGNIZE THE CATHETER. THIS IS BEING REPORTED FOR CANCELLATION OF THE PROCEDURE. DURING A CRYOABLATION PROCEDURE, A SMARTFREEZE CRYO CONSOLE WAS SELECTED FOR USE TO TREAT ATRIAL FIBRILLATION. THE CRYOBALLOON CATHETER, TUBING, AND ELECTRICAL CABLES WERE CONNECTED TO THE CONSOLE; HOWEVER, AFTER THE CONNECTIONS WERE MADE, ALL SYMBOLS (COAXIAL AND ELECTRICAL) ON THE CONSOLE APPEARED RED, AND THE SYSTEM DID NOT RECOGNIZE THE CATHETER. A RESET AND GROUNDING PROCEDURE WAS PERFORMED, THE CABLES WERE RECONNECTED, AND ALL CONNECTIONS WERE RECHECKED, BUT THE PROBLEM PERSISTED. SUBSEQUENTLY, THE CATHETER WAS REPLACED, AND THE ENTIRE PROCEDURE WAS REPEATED, BUT THE CONSOLE WAS STILL UNABLE TO RECOGNIZE THE CATHETER. CONSEQUENTLY, THE PROCEDURE WAS CANCELLED WITH THE PATIENT BEING SEDATED AND ADMINISTERED WITH DORMICUM. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. IT IS UNKNOWN WHETHER THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23532526 ↗
• MalfunctionMar 18, 2025Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT A TEMPERATURE ISSUE OCCURRED; THE DISPLAYED TEMPERATURE WAS WARMER THAN THE ACTUAL TEMPERATURE. DURING A CRYOABLATION PROCEDURE THE SMARTFREEZE CRYO CONSOLE WAS SELECTED FOR USE. WHEN THE CATHETER WAS CONNECTED TO THE CONSOLE, IT DISPLAYED THE TEMPERATURE APPROXIMATELY 28-30 DEGREES WARMER THAN THE ACTUAL TEMPERATURE. THE POLARX CATHETER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITHOUT PATIENT COMPLICATIONS. AS THIS ERROR OCCURRED WITH THIS CONSOLE IN ANOTHER CASE IT WAS SUSPECTED THE CONSOLE WAS THE ISSUE, AND FIELD SERVICE REPAIR WAS REQUESTED. THE FLOWMETER AND VALVE WERE REPLACED. THE CONSOLE HAS YET TO BE USED SINCE THIS REPAIR TOOK PLACE. AS THE DEVICE WAS REPAIRED ONSITE, IT IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21630739 ↗
• MalfunctionMar 3, 2025Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT A TEMPERATURE ISSUE OCCURRED; THE DISPLAYED TEMPERATURE WAS WARMER THAN THE ACTUAL TEMPERATURE. DURING A CRYOABLATION PROCEDURE THE SMARTFREEZE CRYO CONSOLE WAS SELECTED FOR USE. WHEN THE CATHETER WAS CONNECTED TO THE CONSOLE, IT DISPLAYED THE TEMPERATURE APPROXIMATELY 28-30 DEGREES WARMER THAN THE ACTUAL TEMPERATURE. THE POLARX CATHETER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITHOUT PATIENT COMPLICATIONS. AS THIS ERROR OCCURRED PREVIOUSLY WITH THIS CONSOLE IN ANOTHER CASE (CAPTURED IN TW #(B)(4)) IT WAS SUSPECTED THE CONSOLE WAS THE ISSUE, AND FIELD SERVICE REPAIR WAS REQUESTED. THE FLOWMETER AND VALVE WERE REPLACED. THE CONSOLE HAS YET TO BE USED SINCE THIS REPAIR TOOK PLACE. AS THE DEVICE WAS REPAIRED ON SITE, IT IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21507923 ↗
• MalfunctionDec 26, 2024Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT THE CONSOLE TEMPERATURE WAS WARMER THAN THE CATHETER TEMPERATURE. A SMARTFREEZE CRYO CONSOLE AND A POLARX CRYO CATHETER WERE SELECTED FOR USE IN A CRYOABLATION PROCEDURE. DURING THE PROCEDURE THE CONSOLE TEMPERATURE DISPLAYED 500 DEGREES. THE POLARX CRYO CATHETER WAS REPLACED BUT THE ISSUE WAS NOT RESOLVED. NO PATIENT COMPLICATIONS OCCURRED. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21019457 ↗
• MalfunctionSep 24, 2024Infusion or Flow Problem; Infusion or Flow Problem

  DURING A MEDICAL EVENT, A SMARTFREEZE DEVICE WAS CHOSEN FOR OPERATION. AN ERROR WAS REPORTED, SPECIFICALLY AN RFO, INDICATING A REFRIGERANT FLOW OBSTRUCTION DETECTED. THIS INCIDENT TOOK PLACE EXTERNAL TO THE PATIENT. THERE IS NO INFORMATION AVAILABLE REGARDING THE DEVICE'S RETURN. CONSEQUENTLY, THE PROCEDURE WAS TERMINATED. IT REMAINS UNCLEAR WHETHER THE PATIENT WAS UNDER SEDATION WHEN THE ISSUE AROSE. IT IS UNKNOWN IF THE DEVICE WILL BE AVAILABLE FOR RETURN. DURING A FIELD SERVICE VISIT, THE CRYO-CONNECTOR, MICRON FILTER, AND CHECK VALVE SUB-ASSEMBLY (CV6) WERE REPLACED; HOWEVER, THE RFO ERROR PERSISTED. FURTHER INSPECTION REVEALED A LEAK IN THE CRBS SOLENOID VALVE ASSEMBLY SV1. IN THE SECOND SERVICE INTERVENTION, BOTH SV1 AND THE CRBS SOLENOID VALVE ASSEMBLY SV9 WERE REPLACED. HOWEVER, THE ABLATION TEST FAILED DUE TO AN OUTER BALLOON PRESSURE ERROR. A THIRD REPLACEMENT WAS CONDUCTED, WHICH INCLUDED THE CRBS CRYO-CONNECTOR WITH TYGON TUBING ASSEMBLY AND THE CRBS SV9 EXTENSION TUBING ASSEMBLY. THIS FINAL INTERVENTION SUCCESSFULLY RESOLVED BOTH THE FUNCTIONAL AND ABLATION TEST ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20292424 ↗
• MalfunctionSep 20, 2024Increase in Pressure; Infusion or Flow Problem; Increase in Pressure; Infusion or Flow Problem

  IT WAS REPORTED THAT DURING A PROCEDURE A SMARTFREEZE CRYO CONSOLE WAS SELECTED FOR USE. HOWEVER, AFTER THE TRANSSEPTAL PUNCTURE, THE PHYSICIAN ADVANCED THE CATHETER TO THE LEFT ATRIUM AND INFLATED THE BALLOON BUT AFTER A FEW SECONDS THE CONSOLE STOPPED, AND THE ERROR MESSAGE, OUTER BALLOON PRESSURE IS TOO HIGH APPEARED ON THE SCREEN. THE PHYSICIAN REPLACED THE GAS CABLE AND TRIED AGAIN BUT THE ISSUE PERSISTED. THEN HE DECIDED TO REPLACE THE CATHETER AND TRIED AGAIN AND AFTER A FEW SECONDS OF ABLATION, THE ERRORS; INNER BALLOON PRESSURE IS TOO HIGH, OUTER BALLOON PRESSURE IS TOO HIGH AND REFRIGERANT FLOW OBSTRUCTION DETECTED APPEARED ON THE SCREEN. ONCE AGAIN, THE PHYSICIAN REPLACED THE CATHETER BUT OBSERVED THE SAME ERRORS. ON THE 3RD CATHETER IT WAS OBSERVED THAT THE ABOVE ERRORS WERE APPEARING ALSO OUTSIDE OF PATIENT'S BODY DURING CATHETER'S CHECK. THEREFORE, HE TRIED TO PERFORM AN APPLICATION WITH THE CATHETER INTO THE WATER (OUTSIDE OF PATIENT'S BODY) WITHOUT APPLYING ANY PRESSURE TO THE BALLOON AND AGAIN THE ERRORS APPEARED. THE PROCEDURE WAS CANCELLED WITH NO PATIENT COMPLICATIONS. THERE IS CURRENTLY NO INFORMATION AVAILABLE REGARDING THE RETURN AVAILABILITY OF THE DEVICE FO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20266611 ↗
• MalfunctionSep 16, 2024Increase in Pressure; Infusion or Flow Problem; Increase in Pressure; Infusion or Flow Problem

  A POLARX SYSTEM WAS SELECTED FOR USE. UPON SETTING UP THE SYSTEM AND TESTING THE POLARX CRYOBALLOON PRIOR TO PATIENT INSERTION BY INFLATING THE BALLOON, AN ERROR MESSAGE DISPLAYED: "ERROR MESSAGE: THE INJECTION PRESSURE IS TOO HIGH." ATTEMPTS TO RESOLVE THE ISSUE INCLUDED DISCONNECTING AND RECONNECTING THE GAS AND ELECTRICAL CABLES, REPLACING BOTH CABLES, RESTARTING THE CONSOLE, REINSTALLING THE GAS TANK, AND REPLACING THE POLARX BALLOON CATHETER WITH A NEW ONE. NONE OF THESE ACTIONS RESOLVED THE ERROR CODE. ADDITIONALLY, A NEW ERROR CODE WAS ENCOUNTERED: "ERROR MESSAGE: REFRIGERANT FLOW OBSTRUCTION DETECTED." ULTIMATELY, THE PROCEDURE WAS ABORTED. IT IS UNKNOWN IF THE DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20232338 ↗
• MalfunctionSep 4, 2024Increase in Pressure; Increase in Pressure

  THE SMARTFREEZE CRYO CONSOLE WAS SELECTED FOR USE IN CRYO PULMONARY VEIN ISOLATION. DURING THE PREPARATION, THE CATHETER WAS CONNECTED TO THE CRYO CONSOLE, AND THE POLARMAP WAS PROPERLY ADVANCED OUT OF THE INNER LUMEN. THE CONSOLE MAINTAINED A PROPER VACUUM. HOWEVER, DURING INFLATION UNDER SALINE, AN ERROR OCCURRED, AND THE BALLOON AUTOMATICALLY DEFLATED. THE ERROR INDICATED THAT THE OUTER BALLOON PRESSURE WAS TOO HIGH (ERROR 1-00000020-2). AFTER CLEARING THE ERROR AND ATTEMPTING INFLATION AGAIN, THE SAME ISSUE AROSE, LEADING TO AUTOMATIC DEFLATION WITHIN LESS THAN 10 SECONDS. SUBSEQUENTLY, THE BALLOON WAS REPLACED. THE SECOND POLARX FIT BALLOON UNDERWENT THE SAME PREPARATION AND WAS CONNECTED USING THE ORIGINAL CABLE AND GAS TUBING. DESPITE A FUNCTIONING VACUUM, THE BALLOON DEFLATED AUTOMATICALLY UPON INFLATION DUE TO THE SAME ERROR. REPLACING THE CRYO GAS CABLE DID NOT RESOLVE THE ISSUE. A THIRD POLARX FIT BALLOON WAS THEN USED WITH THE SECOND CRYO CABLE, BUT THE PROBLEM PERSISTED. FIELD SUPPORT WAS CONTACTED, THE ELECTRICAL CABLE WAS REPLACED, YET THE ERROR REMAINED. EVEN AFTER SWITCHING THE GAS TANK AND REBOOTING THE SMARTFREEZE CONSOLE, THE ERROR CONTINUED. ULTIMATELY, THE PRO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20139075 ↗
• MalfunctionAug 14, 2024Increase in Pressure; Increase in Pressure

  IT WAS REPORTED THAT DURING A PROCEDURE A SMARTFREEZE CONSOLE WAS SELECTED FOR USE. HOWEVER, THE ERROR MESSAGE THE "INJECTION PRESSURE IS TOO HIGH", WAS DISPLAYED. THE PHYSICIAN DECIDED THEN TO REPLACE SEVERAL TIMES BALLOON CATHETER AND GAS CABLES, ALSO RESTARTED THE CONSOLE AND A LINE PURGING VIA TANK CHANGE SCREEN, BUT THE ISSUE PERSISTED. THEREFORE, THE PROCEDURE WAS CANCELLED. THERE IS NO INFORMATION ABOUT THE AVAILABILITY OF THE DEVICE FOR RETURNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19987996 ↗
• MalfunctionAug 8, 2024Increase in Pressure; Increase in Pressure

  THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER SEDATION. DURING AN ATRIAL FIBRILLATION ABLATION, A SMARTFREEZE CONSOLE WAS USED. THE ERROR 1-00000020-2 INDICATING HIGH OUTER BALLOON PRESSURE (OBP) WAS ENCOUNTERED. DESPITE REPLACING THE GAS CABLE AND CATHETER, THE ISSUE PERSISTED. THE PROCEDURE WAS THEN CANCELLED, NO PATIENT COMPLICATIONS HAD OCCURRED. THE BALLOON WAS NOT INSIDE THE PATIENT AT THE TIME. IT REMAINS UNCERTAIN WHETHER THE DEVICE WILL BE AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19946219 ↗
• MalfunctionJun 24, 2024Unexpected Shutdown; Unexpected Shutdown

  DURING AN ABLATION PROCEDURE A SMARTFREEZE CRYO CONSOLE WAS SELECTED FOR USE. IT WAS REPORTED THAT WHILE COOLING THE PULMONARY VEINS (APPROXIMATELY 150 SECONDS AFTER COOLING BEGAN), SMARTFREEZE POWER WENT OUT. THE SYSTEM WAS REBOOTED, AND THE PROCEDURE WAS COMPLETED USING THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19600640 ↗
• MalfunctionJun 5, 2024Connection Problem; Unexpected Shutdown; Connection Problem; Unexpected Shutdown

  IT WAS REPORTED THAT THE CRBS SMARTFREEZE CRYO CONSOLE WAS SELECTED FOR USE, THE CLIP SECURING THE POWER CABLE ON THEIR POLARX CONSOLE HAS COME OFF AND THE POWER CABLE IS LOOSE CAUSING THE CONSOLE TO SHUT DOWN INADVERTENTLY. IT HAPPENS A COUPLE OF TIMES THAT THE POWER CABLE GOT LOSE AND THE CONSOLE SHUT DOWN, BUT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE DEVICE IS NOT EXPECTED TO BE RETURNED. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE SMARTFREEZE CONSOLE IS WORKING WELL. A NEW CLIP IS BEING SENT TO SECURE THE POWER CABLE AND IT WILL BE INSTALLED BY THE LOCAL SERVICE ENGINEER. IT HAPPENS A COUPLE OF TIMES THAT THE POWER CABLE GOT LOSE AND THE CONSOLE SHUT DOWN, BUT THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19471832 ↗
• MalfunctionApr 9, 2024Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING A CRYOABLATION, AS THEY STARTED THE CASE, EVERYTHING WAS PLUGGED IN AND WAITING. THE PHYSICIAN PULLED THE VACUUM PREPPED THE BALLON AND GOT ACCESS TO LEFT SUPERIOR PULMONARY VEIN (LSPV), THEN INFLATED THE BALLOON THE FIRST TIME WITH THE CONSOLE SCREEN. AS THE BALLOON WENT TO INCREASE THE SIZE OF THE BALLOON TO 31MM THE TEAM GRABBED THE REMOTE, AND IT WAS VIBRATING. THE BALLOON WAS ABLE TO INCREASE SIZE 31MM WITH THE PRESS OF A BUTTON ON REMOTE. UPON ABLATION OF THE LSPV, THE ABLATION TEMPERATURE REACHED 67 DEGREES AND THE ESOPHAGEAL TEMPERATURE WAS 25 DEGREES, SO THE PHYSICIAN REQUESTED TO COME OFF ABLATION. WHEN THE ORANGE ABLATION OFF BUTTON WAS PRESSED ON THE CONTROLLER, THERE WAS NO FEEDBACK AS IT WAS VIBRATING, THEREFORE THEY DID NOT THINK IT STOPPED THE ABLATION. THE STOP BUTTON WAS PRESSED ON THE CONSOLE SCREEN, WHICH HARD STOPPED THE ABLATION. THEY UNPLUGED THE REMOTE CONTROL, PLUGGED IT BACK IN AND THE VIBRATING STOP. THE PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATIONS. THE DEVICE IS NOT EXPECTED TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19074033 ↗
• MalfunctionMar 27, 2024Defective Device; Gas/Air Leak; Infusion or Flow Problem; Temperature Problem; Defective Device; Gas/Air Leak; Infusion or Flow Problem; Temperature Problem

  DURING A ATRIAL FIBRILLATION (A FIB) PROCEDURE A SMARTFREEZE CRYO CONSOLE WAS SELECTED FOR USE. AFTER PERFORMING THREE SUCCESSFUL ABLATIONS ON THE LEFT SIDE, THEN TO THE RIGHT SUPERIOR PULMONARY VEIN (RSPV) WITHIN THE FIRST FREEZE A LOW TEMPERATURE ERROR OCCURRED. THE TEMPERATURE REACHED -72 WITHIN 20 SECONDS. THE PHYSICIAN MUST HAVE BEEN TOO DEEP IN THE VEIN AND WAS NOT USING FLUORO AND GOING OFF OF WAVEFORMS. THE LOW TEMPERATURE ERROR WAS CLEARED AND NOW WAITING FOR BALLOON TO THAW. DURING THE THAWING PROCESS A REFRIGERANT FLOW OBSTRUCTION ERROR OCCURRED. TROUBLESHOOTING INCLUDES A COMBINATION OF TURNING OFF THE VACUUM, ROTATING THE CRYO CABLE 180 DEGREES, RECONNECTING THE CABLE, AND REINITIATING THE VACUUM. THE ERROR CODE COULD NOT BE CLEARED. ADDITIONAL TROUBLESHOOTING INCLUDES REPLACING THE CRYO CABLE AND REINITIATING THE VACUUM, STILL THE ERROR CODE PERSISTED. THEN A HARDWARE PROBLEM ERROR MESSAGE OCCURRED. DURING THIS TIME OF TROUBLESHOOTING, TECHNICAL SUPPORT WAS CALLED FOR ADDITIONAL ASSISTANCE. AFTER WAITING 5 MINUTES THE VACUUM WAS REINITIATED AGAIN AND THE HARDWARE ERROR PERSISTED. A NEW BALLOON AND CRYO CABLE WERE ALSO OPENED DURING THIS TIME AS A METHOD OF TROUBLESHOO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18987714 ↗

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