SMARTFREEZE™ M004CRBS4000Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 08714729992691), received between Aug 28, 2023 and Dec 22, 2025 — classified as 1 injury, 32 malfunctions.

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

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-0303-2025 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, 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 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 15, 2024Increase in Pressure; Increase in Pressure

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION WITH A SMARTFREEZE CONSOLE, ERROR 1 - 00000020-2: OUTER BALLOON PRESSURE IS TOO HIGH WAS DISPLAYED DURING CASE. THE ISSUE WAS IDENTIFIED DURING INFLATION AND WAS OBSERVED IN RIPV AND RSPV. TROUBLESHOOTING PERFORMED INCLUDED DISCONNECTING AND RECONNECTING THE CRYO CABLE, REPLACEMENT OF CRYO CABLE AND BALLOON, AND A POWER CYCLE. NO DEFECTS WERE OBSERVED IN THE CATHETER. THE CONSOLE WAS REPLACED DUE TO A FAULTY SV9 VALVE. NO PATIENT COMPLICATIONS OCCURRED. THE PHYSICIAN DECIDED TO ABORT THE CRYO ABLATION AND PROCEED WITH RADIOFREQUENCY (RF). THIS EVENT IS BEING REPORTED DUE TO PROCEDURE CANCELLATION WHILE THE PATIENT WAS UNDER GENERAL SEDATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18916834 ↗
• MalfunctionMar 14, 2024Infusion or Flow Problem; Infusion or Flow Problem

  DURING A PROCEDURE A SMARTFREEZE WAS SELECTED FOR USE. IT WAS REPORTED THAT PREPARATION WAS ACCORDING RECOMMENDED PROCEDURAL STEPS. THE BALLOON CATHETER WAS UNPACKED, CONNECTED WITH THE ELECTRICAL CABLE AND CRYO CABLE TO THE SMARTFREEZE CONSOLE, THEN THE VACUUM WAS TURNED ON. THE POLARX CATHETER AND POLARMAP WERE SUBMERGED INTO SALINE. THE PHYSICIAN PREPARED THE BALLOON PER INSTRUCTION, POSITIONED THE BALLOON IN LSPV AND STARTED WITH ABLATION. SEVERAL SECONDS LATER THE CONSOLE DISPLAYED THE ERROR 2 - 00000008-1: REFRIGERANT FLOW OBSTRUCTION DETECTED. TROUBLESHOOTING WAS PERFORMED, THE CRYO CABLE WAS DISCONNECTED AND RECONNECTED, THE VACUUM WAS TURNED ON AGAIN. BUT WHEN THE ABLATION STARTED THE ERROR APPEARED. TROUBLESHOOTING PROCESS WAS REPEATED BUT ISSUE PERSISTED. THE CRYO CABLE WAS REPLACED, THE CONNECTIONS WERE REESTABLISHED, THE VACUUM WAS TURNED ON AND THE PROCEDURE CONTINUED, BUT WHEN THE ABLATION WAS STARTED THE SAME ERROR WAS DISPLAYED. TROUBLESHOOTING PROCESS WAS REPEATED BUT ISSUE WAS STILL PRESENT. THE CATHETER WAS REPLACED, ALL STEPS WERE REPEATED, BUT WHEN ABLATION WAS STARTED THE ERROR WAS DISPLAYED AGAIN. THE PATIENT WAS NOT HARMED OR IN DANGER DURING THE TROUBLESHO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18907201 ↗
• MalfunctionMar 14, 2024Operating System Becomes Nonfunctional; Operating System Becomes Nonfunctional

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE A SMARTFREEZE CRYO CONSOLE WAS SELECTED FOR USE. THE CONSOLE SCREEN FROZE AND ABLATION TIME, TEMPERATURE AND CURVE WAS NOT VISIBLE, AND SHORTLY AFTER THE ISOLATION THE ABLATION HAD TO BE STOPPED WITH 'EMERGENCY BUTTON'. IT RESULTED IN NEED FOR 3 APPLICATIONS IN THE LIPV. THE CONSOLE WAS RESTARTED AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT COMPLICATIONS. THE CONSOLE WILL NOT BE AVAILABLE FOR RETURN AS IT WILL BE RETAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18904232 ↗
• MalfunctionMar 13, 2024Increase in Pressure; Increase in Pressure

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A SMARTFREEZE WAS SELECTED FOR USE. IT WAS REPORTED THAT THE ERROR 1 - 00000020-2: OUTER BALLOON PRESSURE IS TOO HIGH WAS DISPLAYED DURING CASE. TROUBLESHOOTING PERFORMED, THE CRYO-CABLE DISCONNECT/RECONNECT, REPLACEMENT OF CRYO-CABLE AND BALLOON, POWER CYCLE. NO DEFECTS OBSERVED IN THE CATHETER. THE PROCEDURE WAS CANCELED. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE HAS BEEN RETURNED FOR ANALYSIS. THIS EVENT IS BEING REPORTED DUE TO PROCEDURE CANCELLATION WHILE THE PATIENT WAS UNDER GENERAL SEDATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18895452 ↗
• MalfunctionMar 8, 2024Gas/Air Leak; Adverse Event Without Identified Device or Use Problem; Gas/Air Leak; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SMARTFREEZE CONSOLE HAD A GAS LEAK. THE ISSUE OCCURRED OUTSIDE OF THE PATIENT. THERE WAS NO PATIENT INVOLVEMENT. IT IS UNKNOWN IF THE DEVICE WILL BE AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18865524 ↗
• MalfunctionFeb 27, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT ERROR 2 - 00000008 REFRIGERANT FLOW OBSTRUCTION DETECTED OCCURRED.DURING A PULMONARY VEIN ISOLATION (PVI) PROCEDURE, A SMARTFREEZE CRYOABLATION SYSTEM CONSOLE WAS SELECTED FOR USE. APPROXIMATELY HALF-WAY THROUGH THE PROCEDURE, AFTER COMPLETION OF ABLATIONS ON THE LEFT SIDE OF THE HEART, THE DEVICE WAS MOVED TO THE RIGHT SIDE. DURING ABLATION, ERROR 2 - 00000008 REFRIGERANT FLOW OBSTRUCTION DETECTED OCCURRED. THE CRYO GAS CABLE CONNECTIONS WERE CHECKED AS WELL AS REPLACEMENT OF THE CABLE, CATHETER, AND TANK, HOWEVER THE ISSUE PERSISTED. THE PROCEDURE WAS ABORTED PRIOR TO COMPLETION OF ABLATIONS ON THE RIGHT SIDE. THERE WERE NO PATIENT COMPLICATIONS. THE DEVICE WILL NOT BE RETURNED, AS ONSITE REPAIR WAS PERFORMED. REPLACEMENT OF PV1 RESOLVED THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18791135 ↗
• MalfunctionFeb 19, 2024Temperature Problem; Temperature Problem

  THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER SEDATION. DURING A CRYO ABLATION WITH POLARX FIT A SMARTFREEZE CRYO CONSOLE WAS SELECTED FOR USE. FOLLOWING A GAS BOTTLE EXCHANGE, NO TEMPERATURES RECORDED REACHED LOWER THAN -30 DEGREES. FLOW AND PRESSURE DURING ABLATION WHERE ABOUT 9000 AND 590. TROUBLESHOOTING INCLUDES RESTARTING THE CONSOLE, DISCONNECT AND RECONNECT THE GAS BOTTLE, AND EXCHANGE OF THE GAS CABLE. THE ISSUE COULD NOT BE RESOLVED. THE PATIENT WAS UNDER GENERAL ANESTHESIA WHEN THE PROCEDURE WAS CANCELLED/ RESCHEDULED. THE DEVICE IS NOT EXPECTED TO RETURN THE PHYSICIAN REQUEST ONSITE SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18735986 ↗
• MalfunctionJan 25, 2024Use of Device Problem; Data Problem; Use of Device Problem; Data Problem

  IT WAS REPORTED THAT DURING A CRYO-ABLATION PROCEDURE USING A SMART FREEZE CRYO-CONSOLE THE TIMER STOPPED SHOWING ON THE CONSOLE. DURING AN ABLATION THE SECTION, BELOW THE TEMPERATURE DISPLAY, WAS BLACK INSTEAD OF DISPLAYING THE ABLATION DURATION. TIME AND TEMPERATURE READINGS ALSO BECAME UNAVAILABLE ON THE CONNECTED RECORDING SYSTEM. ABLATION WAS STOPPED AND THE CONSOLE WAS RESTARTED, AND THE ISSUE WAS RESOLVED, IT DID NOT OCCUR AGAIN DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT COMPLICATIONS. THE CONSOLE WILL BE RETAINED BY THE SITE AS THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18581713 ↗
• MalfunctionDec 20, 2023Increase in Pressure; Increase in Pressure

  IT WAS REPORTED THAT PRIOR TO A CRYO PULMONARY VEIN ISOLATION (PVI) PROCEDURE TO TREAT ATRIAL FIBRILLATION A SMARTFREEZE CRYO CONSOLE WAS SELECTED FOR USE. AFTER CONNECTION OF THE CRYO GAS CABLE AND THE POLARXFIT CATHETER, THE ERROR MESSAGE SN (B)(6): THE OUTER BALLOON PRESSURE IS TOO HIGH APPEARED ON THE CRYO CONSOLE DURING THE INITIAL BALLOON INFLATION. THE CRYO GAS CABLE WAS DISCONNECTED THEN RECONNECTED, AND WAS ALSO REPLACED, BUT THE ERROR STILL REPEATED AFTER EACH OF THESE ATTEMPTED FIXES. THE CATHETER WAS REPLACED, BUT THE ERROR CONTINUED. AFTER THAT THE ELECTRICAL EXTENSION CABLE WAS REPLACED, BUT THE ERROR STILL CONTINUED. THE CRYO CONSOLE WAS REPLACE WITH ANOTHER FROM A NEARBY PUBLIC HOSPITAL, BUT THE OUTER BALLOON PRESSURE (OBP) ERROR OCCURRED AGAIN. THE ERROR CONTINUED EVEN AFTER CONNECTING THE SECOND CRYO CONSOLE TO DIFFERENT SCAVENGE PORTS AS WELL. WITH NO RESOLUTION TO THE REPEATED OBP ERRORS, THE PROCEDURE WAS CANCELLED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18366769 ↗
• MalfunctionDec 20, 2023Increase in Pressure; Increase in Pressure

  IT WAS REPORTED THAT PRIOR TO A CRYO PULMONARY VEIN ISOLATION (PVI) PROCEDURE TO TREAT ATRIAL FIBRILLATION A SMARTFREEZE CRYO CONSOLE WAS SELECTED FOR USE. AFTER CONNECTION OF THE CRYO GAS CABLE AND THE POLARXFIT CATHETER, THE ERROR MESSAGE SN (B)(6): THE OUTER BALLOON PRESSURE IS TOO HIGH APPEARED ON THE CRYO CONSOLE DURING THE INITIAL BALLOON INFLATION. THE CRYO GAS CABLE WAS DISCONNECTED THEN RECONNECTED, AND WAS ALSO REPLACED, BUT THE ERROR STILL REPEATED AFTER EACH OF THESE ATTEMPTED FIXES. THE CATHETER WAS REPLACED, BUT THE ERROR CONTINUED. AFTER THAT THE ELECTRICAL EXTENSION CABLE WAS REPLACED, BUT THE ERROR STILL CONTINUED. THE CRYO CONSOLE WAS REPLACE WITH ANOTHER FROM A NEARBY PUBLIC HOSPITAL, BUT THE OUTER BALLOON PRESSURE (OBP) ERROR OCCURRED AGAIN. THE ERROR CONTINUED EVEN AFTER CONNECTING THE SECOND CRYO CONSOLE TO DIFFERENT SCAVENGE PORTS AS WELL. WITH NO RESOLUTION TO THE REPEATED OBP ERRORS, THE PROCEDURE WAS CANCELLED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18366296 ↗
• MalfunctionDec 6, 2023Increase in Pressure; Increase in Pressure

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING A SMARTFREEZE CRYOABLATION CONSOLE, THE SYSTEM PRESENTED THE ERROR SN (B)(6): THE OUTER BALLOON PRESSURE IS TOO HIGH. REPLACING THE CATHETER AND ITS CABLE DID NOT SOLVE THE PROBLEM, SO THE GAS CABLE CONNECTION WAS AND THEN THE CABLE AND BALLOON WERE REPLACED, BUT THE ERROR RECURRED NINE MORE TIMES WITH DIFFERENT COMBINATIONS. ALL OCCURRED OUTSIDE THE PATIENT AND NO PATIENT COMPLICATIONS ARE REPORTED. INITIALLY WE HAD BEEN INFORMED THAT THE PROCEDURE WAS CANCELLED, HOWEVER, IT WAS FURTHER REPORTED THAT A NON-BOSTON SCIENTIFIC SYSTEM WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18275388 ↗
• MalfunctionNov 6, 2023Increase in Pressure; Increase in Pressure

  TWO POLARX BALLOON CATHETERS AND A SMARTFREEZE CONSOLE WERE SELECTED FOR A CRYOABLATION PROCEDURE. IT WAS REPORTED THAT DURING THE PROCEDURE THE ERROR CODE "SN (B)(6) : THE OUTER BALLOON PRESSURE IS TOO HIGH" OCCURRED ON THE SECOND CRYOABLATION ATTEMPT AND A DAMAGE ON THE TIP OF THE CATHETER WAS NOTED. ALL CABLES WERE CHECKED, RECONNECTED AND THE GAS CABLE WAS CHANGED, BUT THE ERROR PERSISTED. SO, THE BALLOON CATHETER WAS REPLACED. THEN AGAIN WHEN THE SECOND ABLATION WAS ATTEMPTED AND THE BALLOON INFLATED, THE SAME ERROR PERSISTED. SO, THE PROCEDURE WAS STOPPED, AND THE REMAINING CRYOABLATION APPLICATIONS RESCHEDULED. NO PATIENT COMPLICATIONS REPORTED, AND THE DEVICE RETURNED IS UNKNOWN. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER SEDATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18075047 ↗

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-0297-2025 · Oct 10, 2024 · Open, Classified
  Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000.
• Z-0300-2025 · Oct 10, 2024 · Open, Classified
  Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060
• Z-0302-2025 · Oct 10, 2024 · Open, Classified
  Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS2160
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