NA 106A3 (UDI 00763000011147)Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00763000011147), received between Jul 2, 2018 and Sep 2, 2026 — classified as 40 injuries, 1 malfunction.

The most frequently reported specific device problem is “Protective Measures Problem” (26 reports).

2 other recalls cover devices cleared under the same FDA submission (P020045); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• InjurySep 2, 2026Protective Measures Problem; No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50567859 ↗
• InjuryJun 2, 2026Infusion or Flow Problem; Adverse Event Without Identified Device or Use Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THERE WAS A PROBLEM WITH THE SYSTEM, AND A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION. TROUBLESHOOTING STEPS INCLUDED REPLACING THE CATHETER, AUTO CONNECTION BOX, COAXIAL UMBILICAL CABLE, AND ELECTRICAL UMBILICAL CABLE, RESTARTING THE CONSOLE, AND TURNING OFF OTHER EQUIPMENT TO ELIMINATE ELECTRICAL INTERFERENCE, BUT THE ISSUE WAS NOT RESOLVED. THE CASE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25363799 ↗
• InjuryFeb 11, 2026Gas/Air Leak; Adverse Event Without Identified Device or Use Problem; Protective Measures Problem

  DURING A LATER SERVICING, THE RELIEF VALVE WAS IDENTIFIED TO HAVE BEEN LEAKING AS WELL AS S4 AND S5 BEING IDENTIFIED AS ISSUE POINTS. THE RELIEF VALVE WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24312782 ↗
• InjuryDec 19, 2025Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING USE, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE REFRIGERANT DELIVERY PATH WAS OBSTRUCTED. THE REFRIGERANT TANK WAS ENSURED TO BE OPEN, THE UMBILICAL CABLE WAS DISCONNECTED AND RECONNECTED, AND THE CATHETER WAS REPLACED WITHOUT RESOLVE. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS TAKEN OFF THE TABLE. IT IS UNKNOWN IF THE PATIENT WAS UNDER GENERAL ANESTHESIA. TECHNICAL SERVICES ADVISED CONFIRMING THE COAX PORT WAS CLEAR OF OBSTRUCTIONS AND REQUESTED DATA FILES, WITH A PENDING INVESTIGATION OF THE COAX PORT PRIOR TO FURTHER SERVICE RECOMMENDATIONS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23851734 ↗
• InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Protective Measures Problem; Adverse Event Without Identified Device or Use Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE USING THE CATHETER AFAPRO28 AFA PRO 28, AFTER THE CRYOBALLOON CATHETER WAS CONNECTED TO THE CONSOLE AND ALL SELF-SAFETY TESTS AND FLUSHING PROCEDURES WERE COMPLETED, BALLOON INFLATION AND LEFT SUPERIOR PULMONARY VEIN OCCLUSION WERE ACHIEVED ON THE FIRST ATTEMPT. DURING THE FIRST CRYOABLATION ATTEMPT, THE TEMPERATURE FAILED TO DROP BELOW -20 DEGREES CELSIUS, AND A SYSTEM NOTICE INDICATED THAT THE REFRIGERANT DELIVERY PATH WAS OBSTRUCTED. THE CRYOABLATION WAS TERMINATED BEFORE REACHING THE ONE-MINUTE MARK. THE VACUUM WAS RELEASED AND REACTIVATED TO ENABLE A NEW SYSTEM CHECK AND FLUSHING PROCEDURE. MULTIPLE ATTEMPTS AT CRYOABLATION WERE MADE, AND THE CRYOBALLOON CATHETER, COAXIAL UMBILICAL, AND ELECTRICAL CABLES WERE REPLACED. A FULL CONSOLE RESET WAS PERFORMED, BUT THE SAME ERROR PATTERN PERSISTED. THE PROCEDURE WAS ABORTED UNDER GENERAL ANESTHESIA. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23829557 ↗
• InjuryDec 11, 2025Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE MINIMUM TEMPERATURE FOR THE CONSOLE TO PERFORM THE TESTS AND ALLOW CRYOABLATION THERAPY WAS NOT REACHED. TECHNICAL SERVICES WERE CALLED AND GAVE INSTRUCTIONS TO CHANGE THE POWER SOURCE. THE POWER SOURCE WAS EXCHANGED FOUR TIMES AND CONSUMABLES WERE EXCHANGED WITHOUT RESOLVE. THE CASE WAS ABORTED. THE PATIENT WAS UNDER GENERAL ANESTHESIA. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23779982 ↗
• InjuryJul 15, 2025Protective Measures Problem; Appropriate Device Problem Term/Code Not Available; Protective Measures Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE USING THE ELECTROPHYSIOLOGY (EP) CATHETER, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SYSTEM DETECTED A TEMPERATURE DROP DURING THE SYSTEM FLUSH, AND THE SYSTEM FLUSH WAS STOPPED. THERE WAS NO SALINE FLUSH DURING THE PROCEDURE, AND THE SYSTEM FLUSH COULD NOT BE STARTED. THE OPERATOR REPORTED CHANGING THE CATHETER, ELECTRICAL UMBILICAL, AND AUTO CONNECTION BOX WITHOUT RESOLUTION. . THE RADIOFREQUENCY GENERATOR WAS OFF. TECHNICAL SERVICES ENSURED THE CATHETER TIP WAS OUT OF THE SHEATH AND IN CONTACT WITH BLOOD, CONFIRMED THE CONSOLE WAS ON ITS OWN OUTLET, AND SUGGESTED TURNING OFF A WARMING DEVICE. A BACKUP CONSOLE WAS OBTAINED AND FUNCTIONED NORMALLY. TEST ABLATIONS WERE PERFORMED SUCCESSFULLY, AND DATA FILES WERE REVIEWED BY TECHNICAL SERVICES. CALIBRATION OF TEMPERATURES WAS PERFORMED TWICE, AND BOTH FINAL AND EXTENDED SELF TESTS WERE COMPLETED PER MANUFACTURER¿S SPECIFICATIONS. TECHNICAL SERVICES NOTED PRESSURE MISMATCHES CHARACTERISTIC OF AN INJECTION PROPORTIONAL VALVE PROBLEM AND RECOMMENDED SERVICE, INCLUDING REPLACEMENT OF THE INJECTION PROPORTIONAL VALVE AND CHECKING TEMPERATURE CALIBRATION. TECHNICAL SERVICES ALSO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22506228 ↗
• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Protective Measures Problem; Adverse Event Without Identified Device or Use Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, A SYSTEM NOTICE INDICATED THAT THE SAFETY SYSTEM DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION. THE ELECTRICAL UMBILICAL CABLE AND AUTO CONNECTION BOX WERE REPLACED, WITHOUT RESOLUTION. TECHNICAL SERVICES RECOMMENDED SEVERAL TROUBLESHOOTING STEPS, INCLUDING CATHETER REPLACEMENT, CHANGING THE POWER OUTLET, TURNING OFF THE BEAR HUGGER, AND REMOVING ELECTROCARDIOGRAM CABLES, BUT THE SYSTEM NOTICE PERSISTED. THE PROCEDURE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. TEST ABLATIONS WERE PERFORMED OUTSIDE THE LAB, AND THE SYSTEM ERROR FROM CASE DID NOT APPEAR, HOWEVER OTHER ERRORS SYSTEM NOTICES WERE NOTED, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE REFRIGERANT DELIVERY PATH WAS OBSTRUCTED. AND A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE VACUUM WAS DISABLED DUE TO A PROBLEM WITH THE COAXIAL UMBILICAL CABLE, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED A HIGH LEVEL OF REFRIGERANT FLOW AND STOPPED THE INJECTION. TECHNICAL SERVICES RECOMMENDED PERFORMING TEST INJECTIONS INSIDE AND OUTSIDE THE LAB TO INVESTIGATE POTENTIAL ELECTRICAL INTERFERENCE AND SUGGESTED USING A GROU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22026206 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Protective Measures Problem; Adverse Event Without Identified Device or Use Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING USE, A SYSTEM NOTICE INDICATED THAT THE SAFETY SYSTEM DETECTED A HIGH LEVEL OF REFRIGERANT FLOW AND SUBSEQUENTLY STOPPED THE INJECTION. THE STAFF REBOOTED THE SYSTEM WITHOUT RESOLUTION. THE CASE WAS SWITCHED TO RADIOFREQUENCY (RF). THE CASE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21642498 ↗
• InjuryFeb 25, 2025Adverse Event Without Identified Device or Use Problem; Protective Measures Problem; Temperature Problem; Adverse Event Without Identified Device or Use Problem; Protective Measures Problem; Temperature Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE TEMPERATURE SPIKED. THE ELECTRICAL UMBILICAL CABLE WAS RECONNECTED WITHOUT RESOLUTION. THE COAXIAL UMBILICAL CABLE, AUTO CONNECTION BOX, AND ELECTRICAL UMBILICAL CABLE WERE REPLACED WITHOUT RESOLUTION. THE RADIOFREQUENCY (RF) GENERATOR WAS TURNED OFF WITHOUT RESOLUTION. THE ELECTROPHYSIOLOGY (EP) CATHETER WAS REPLACED WITHOUT RESOLUTION AND A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED A HIGH LEVEL OF REFRIGERANT FLOW AND STOPPED THE INJECTION. THE SYSTEM WAS REBOOTED WITHOUT RESOLUTION. THE CASE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE CONSOLE WAS LATER REPLACED DUE TO THE ISSUES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21460053 ↗
• InjuryOct 21, 2024Leak/Splash; Leak/Splash

  IT WAS LATER NOTED THAT THE HOSPITAL STAFF MEMBER WENT TO THE DOCTOR FOR TREATMENT.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 20501073 ↗
• InjuryOct 2, 2024Mechanical Problem; Infusion or Flow Problem; Adverse Event Without Identified Device or Use Problem; Protective Measures Problem; Mechanical Problem; Infusion or Flow Problem; Adverse Event Without Identified Device or Use Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SYSTEM DETECTED A TEMPERATURE DROP DURING THE SYSTEM FLUSH, AND THE SYSTEM FLUSH WAS STOPPED AND WHAT WAS ASSUMED TO BE A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED A HIGH LEVEL OF REFRIGERANT FLOW AND STOPPED THE INJECTION. THE COAXIAL UMBILICAL CABLE AND BALLOON CATHETER WERE REPLACED WITHOUT RESOLUTION. THE CASE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. TEST INJECTIONS WERE CARRIED OUT, PRESSURE AND FLOW, TANK PRESSURE, AND WEIGHT WERE NOT AS EXPECTED. THE LOW PRESSURE REGULATOR (LPR) WAS NOT AS EXPECTED AND WHILE VENTING, THE LOW PRESSURE REGULATOR (LPR) BATTERY DEPLETED. ADDITIONALLY, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE REFRIGERANT DELIVERY PATH WAS OBSTRUCTED. THE CONSOLE WAS SERVICED AS APPROPRIATE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20354799 ↗
• InjurySep 25, 2024Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE REFRIGERANT DELIVERY PATH WAS OBSTRUCTED. THE COAXIAL UMBILICAL CABLE WAS REPLACED TWICE WITHOUT RESOLVE. THE GAS WAS REPLACED THREE TIMES WITHOUT RESOLVE. THE VACUUM CONNECTION WAS CHANGED WITHOUT RESOLVE. THE CASE WAS ABORTED. THE PATIENT WAS UNDER GENERAL ANESTHESIA. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20298954 ↗
• InjuryMay 2, 2024Adverse Event Without Identified Device or Use Problem; Protective Measures Problem; Adverse Event Without Identified Device or Use Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE REFRIGERANT DELIVERY PATH WAS OBSTRUCTED. THE COAXIAL UMBILICAL CABLE AND CATHETER WERE REPLACED WITHOUT RESOLUTION. THE CASE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. TEST ABLATIONS WERE LATER PERFORMED, AND A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SYSTEM WAS UNABLE TO INITIATE THE SYSTEM FLUSH. IT WAS NOTED THAT THE TANK WAS RECENTLY REPLACED. THE TANK WAS REPLACED, THE CONSOLE WAS VENTED, AND THE COAXIAL CAP WAS TEMPORARILY REMOVED FROM THE CONSOLE WITHOUT RESOLUTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19234687 ↗
• InjuryMar 13, 2024Adverse Event Without Identified Device or Use Problem; Protective Measures Problem; Adverse Event Without Identified Device or Use Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE ELECTROPHYSIOLOGY (EP) CATHETER WAS NOT RECOGNIZED BY THE CONSOLE. THE CASE WAS ABORTED. THE PATIENT WAS UNDER GENERAL ANESTHESIA. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18895211 ↗
• InjuryDec 15, 2023Computer Software Problem; Adverse Event Without Identified Device or Use Problem; Protective Measures Problem; Computer Software Problem; Adverse Event Without Identified Device or Use Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED A HIGH LEVEL OF REFRIGERANT FLOW AND STOPPED THE INJECTION. IT WAS NOTED THERE WAS SUFFICIENT TIP CONTACT. THE ELECTROPHYSIOLOGY (EP) CATHETER WAS REPLACED WITHOUT RESOLVE. THE CASE WAS ABORTED. IT IS UNKNOWN IF THE PATIENT WAS UNDER GENERAL ANESTHESIA. TEST INJECTIONS WERE CARRIED OUT WITHOUT ISSUE. DATA FILES WERE REVIEWED AND THE PATIENT FILE WAS CORRUPTED. PRESSURE AND FLOW WERE AS EXPECTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18333786 ↗
• InjuryNov 1, 2023Adverse Event Without Identified Device or Use Problem; Temperature Problem; Adverse Event Without Identified Device or Use Problem; Temperature Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE TEMPERATURE WAS COLDER THAN EXPECTED. THE AUTO CONNECTION BOX WAS REPLACED AND THE CONSOLE WAS VENTED, BUT THE ISSUE PERSISTED. THE CASE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18052604 ↗
• InjuryOct 24, 2023Infusion or Flow Problem; Adverse Event Without Identified Device or Use Problem; Protective Measures Problem; Infusion or Flow Problem; Adverse Event Without Identified Device or Use Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE LOW PRESSURE REGULATOR (LPR) WAS HIGHER THAN EXPECTED. THE CONSOLE WAS VENTED FIVE TIMES WITHOUT RESOLVE. A NUMBER OF ABLATIONS WERE CARRIED OUT AND THE LOW PRESSURE REGULATOR (LPR) CAME BACK INTO RANGE. THE CASE WAS ABORTED, THE PATIENT WAS UNDER GENERAL ANESTHESIA.  TEST INJECTIONS WERE CARRIED OUT AND A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SYSTEM DETECTED AN ELECTRICAL COMPONENT FAILURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17994747 ↗
• InjurySep 29, 2023Adverse Event Without Identified Device or Use Problem; Protective Measures Problem; Adverse Event Without Identified Device or Use Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THERE WAS A PROBLEM WITH THE OPERATIONAL PARAMETERS FILE. THE AUTO CONNECTION BOX AND ELECTRICAL UMBILICAL CABLE WERE REPLACED AND THE CONSOLE REBOOTED WITHOUT RESOLVE. THE ELECTROPHYSIOLOGY (EP) CATHETER WAS REPLACED WITHOUT RESOLVE. THE CASE WAS ABORTED. THE PATIENT WAS UNDER GENERAL ANESTHESIA. AFTER THE CASE, TEST INJECTIONS WERE CARRIED OUT. IT WAS NOTES THAT THE CATHETER FILES WERE NOT INSTALLED ON THE CONSOLE AND THE CATHETER WAS NOT RECOGNIZED. A PREVENTATIVE MAINTENANCE IS DUE ON THE CONSOLE AND CATHETER SOFTWARE INSTALLATION WAS RECOMMENDED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17841528 ↗
• InjurySep 27, 2023Infusion or Flow Problem; Adverse Event Without Identified Device or Use Problem; Protective Measures Problem; Infusion or Flow Problem; Adverse Event Without Identified Device or Use Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE LOW PRESSURE REGULATOR (LPR) PRESSURE WAS HIGH, SO THE SYSTEM WAS VENTED. THE TEST INJECTIONS WERE COMPLETED SUCCESSFULLY. A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE BALLOON INFLATION PRESSURE WAS NOT REACHED IN TIME. THE BALLOON CATHETER, COAXIAL UMBILICAL CABLE AND ELECTRICAL UMBILICAL CABLE WERE REPLACED WHICH DID NOT RESOLVE THE ISSUE. THE AUTO CONNECTION BOX WAS BYPASSED AND THE ISSUE REMAINED. THE SYSTEM WAS VENTED AGAIN AND THE ISSUE REMAINED. THE CHECK VALVE 7 (CV7)  WAS TAPPED WHICH DID NOT RESOLVE THE ISSUE. NO VEINS WERE ABLATED USING CRYOABLATION. THE PHYSICIAN PROCEEDED WITH THE CAVOTRICUSPID ISTHMUS (CTI) LINE ABLATION USING A RADIOFREQUENCY (RF) CATHETER. THE CRYO ABLATION PROCEDURE FOR PULMONARY VEIN ISOLATION (PVI) WAS ABORTED AND THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE DATA FILES WERE REVIEWED AND CONFIRMED THE SYSTEM NOTICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17826930 ↗
• InjuryJul 14, 2023Infusion or Flow Problem; Adverse Event Without Identified Device or Use Problem; Protective Measures Problem; Temperature Problem; Infusion or Flow Problem; Adverse Event Without Identified Device or Use Problem; Protective Measures Problem; Temperature Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE TEMPERATURES WERE NOT AS EXPECTED WHEN MAPPING. IT WAS FURTHER REPORTED THAT A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED A HIGH LEVEL OF REFRIGERANT FLOW AND STOPPED THE INJECTION. THE COAXIAL UMBILICAL CABLE WAS DISCONNECTED AND RECONNECTED WHICH DID NOT RESOLVE THE SYSTEM NOTICE. THE COAXIAL UMBILICAL CABLE WAS REPLACED, AND THE SYSTEM NOTICE PERSISTED. IT WAS NOTED THAT DURING ABLATIONS THE PRESSURE WAS AS EXPECTED, HOWEVER, THE FLOW APPEARED ERRATIC. THE CONSOLE WAS REBOOTED AND THEN A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE INJECTION WAS STOPPED BECAUSE THE CRYOMAPPING TEMPERATURE EXCEEDED THE PRESET VALUE BY MORE THAN FIFTEEN DEGREES. ON A SUBSEQUENT ABLATION THE TEMPERATURE WAS AS EXPECTED, BUT THE INITIAL SYSTEM NOTICE OCCURRED AGAIN. THE CASE WAS SWITCHED TO RADIOFREQUENCY AND WHEN THE BALLOON CATHETER WAS REMOVED A KINK WAS OBSERVED IN THE CATHETER APPROXIMATELY 3 CENTIMETERS FROM THE DISTAL TIP. WHEN THE PROCEDURE WAS SWITCHED TO RADIOFREQUENCY,  THE PHYSICIAN WAS UNABLE TO OBTAIN A SAFE LOCATION FOR RADIOFREQUENCY. THE CASE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17329980 ↗
• InjuryMay 30, 2023Adverse Event Without Identified Device or Use Problem; Protective Measures Problem; Adverse Event Without Identified Device or Use Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED A HIGH LEVEL OF REFRIGERANT FLOW AND STOPPED THE INJECTION. THE CONSOLE WAS REBOOTED WITHOUT RESOLUTION. THE ELECTRICAL UMBILICAL CABLE, COAXIAL UMBILICAL CABLE, AND BALLOON CATHETER WERE REPLACED WITHOUT RESOLUTION. THE SYSTEM WAS VENTED WITHOUT RESOLUTION. THE PROCEDURE WAS ABORTED. IT WAS LATER REPORTED THAT THE PATIENT WAS UNDER GENERAL ANESTHESIA. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17019690 ↗
• InjuryJan 24, 2023Adverse Event Without Identified Device or Use Problem; Protective Measures Problem; Adverse Event Without Identified Device or Use Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE BALLOON INFLATION PRESSURE WAS NOT REACHED IN TIME. THE LOW PRESSURE REGULATOR (LPR) WAS IN RANGE AND THE COAXIAL UMBILICAL CABLE WAS DISCONNECTED AND RECONNECTED WITHOUT RESOLVE. THE CONSUMABLES WERE REPLACED WITHOUT RESOLVE. THE TANK WAS CHANGED WITHOUT RESOLVE. THE CONSOLE WAS REBOOTED WITHOUT RESOLVE. THE CASE WAS SWITCHED TO RADIOFREQUENCY. THE CASE WAS ABORTED UNDER GENERAL ANESTHESIA. AFTER THE CASE THE CONSOLE LOW PRESSURE REGULATOR (LPR) WAS NOT AS EXPECTED AND THE CONSOLE WAS VENTED. A SERVICE WAS CARRIED OUT AT A LATER DATE AND THE LOW PRESSURE REGULATOR (LPR) WAS REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16233597 ↗
• InjuryJan 17, 2023Leak/Splash; Adverse Event Without Identified Device or Use Problem; Protective Measures Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE REFRIGERANT DELIVERY PATH WAS OBSTRUCTED. THE COAXIAL UMBILICAL CABLE, ELECTRICAL UMBILICAL CABLE, TANK, AUTO CONNECTION BOX, AND BALLOON CATHETER WERE INDIVIDUALLY REPLACED, BUT THE ISSUE PERSISTED. THE CONSOLE WAS ALSO VENTED WITHOUT RESOLUTION. A BACKUP CONSOLE WAS THEN USED, BUT UPON START-UP, THE CATHETER WAS NOT RECOGNIZED AND A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THERE WAS A PROBLEM WITH THE INJECTION PROCESS. THE CONSOLE WAS VENTED, BUT IT WAS NOTED THAT THE CONSOLE WAS VENTING MORE SLOWLY THAN EXPECTED AND WAS UNABLE TO PERFORM ANY INJECTION. IT WAS ALSO REPORTED THAT THE LOW PRESSURE REGULATOR (LPR) WAS DISPLAYING VALUES HIGHER THAN EXPECTED AND THAT FROSTING WAS OCCURRING AROUND SOLENOID 5 (S5) AND THE LPR. THE SCREEN WAS BLACK AND A MESSAGE READING "NO INPUT DETECTED" WAS DISPLAYED. IT WAS NOTED THAT THERE WAS DIFFICULTY REMOVING THE SHEATH AND THAT PRESSURE WAS APPLIED TO THE GROIN ACCESS SITE. THE CASE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16188128 ↗
• MalfunctionJan 6, 2023Infusion or Flow Problem; Protective Measures Problem; Appropriate Device Problem Term/Code Not Available; Noise, Audible; Infusion or Flow Problem; Protective Measures Problem; Appropriate Device Problem Term/Code Not Available; Noise, Audible

  IT WAS REPORTED THAT DURING PREVENTATIVE MAINTENANCE A LOUD POP WAS HEARD AND THE CONSOLE DISPLAYED A "NO INPUT DETECTED" NOTICE. THE LOW PRESSURE REGULATOR (LPR) WAS NOT AS EXPECTED AND THE CONSOLE WAS VENTED TO RESOLVE. A NEW POWER SUPPLY WAS INSTALLED. IT WAS ALSO REPORTED THAT THERE WAS BLOOD IN THE CONSOLE. THE CONSOLE WAS SERVICED AS APPROPRIATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16117680 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P020045. One submission often covers many models, so check the product and lot details in each record.

• Z-2777-2015 · Sep 1, 2015 · Terminated
  Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing cardiac ablation procedures.
• Z-1452-06 · Aug 4, 2006 · Terminated
  7F Freezor Cardiac Cryoablation catheter, REF # 207F1. CryoCath Technologies Inc.