NA 106A3 (UDI 00643169352476)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00643169352476), received between Feb 28, 2017 and Dec 3, 2024 — classified as 18 injuries, 1 malfunction.

The most frequently reported specific device problem is “Protective Measures Problem” (7 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryDec 3, 2024Mechanical Problem; Infusion or Flow Problem; Adverse Event Without Identified Device or Use Problem; Power Problem; Protective Measures Problem; Mechanical Problem; Infusion or Flow Problem; Adverse Event Without Identified Device or Use Problem; Power Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE CONSOLE WOULD NOT POWER ON DURING THE CASE, THE CONSOLE WAS SWITCHED FOR ANOTHER TO RESOLVE THE ISSUE. THE CASE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. DURING A LATER SERVICING, THE POWER SUPPLY WAS REPLACED AND UNKNOWN POWER TEST ERROR WAS RECEIVED. DURING ANOTHER LATER SERVICING, THE BOARDS AND CONNECTIONS WERE RESEATED AND THE CONSOLE WAS REBOOTED. IT WAS ALSO REPORTED THAT THE CONSOLE HAD NO FLOW. DURING A THIRD LATER SERVICING, THE PRESSURE TRANSDUCER ONE (PT1) WAS RECONNECTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20833692 ↗
• InjuryAug 23, 2024Infusion or Flow Problem; Protective Measures Problem; No Apparent Adverse Event; Insufficient Device Problem Information; Infusion or Flow Problem; Protective Measures Problem; No Apparent Adverse Event; Insufficient Device Problem Information

  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 TWICE, AND THE ELECTROPHYSIOLOGY (EP) CATHETER, COAXIAL UMBILICAL CABLE AND AUTO CONNECTION BOX WERE REPLACED WITHOUT RESOLUTION. TEST INJECTIONS WERE PERFORMED AND THE ELECTRICAL UMBILICAL CABLE WAS REPLACED WITHOUT RESOLUTION. THE TANK WAS REPLACED AND THE CONSOLE WAS VENTED WITHOUT RESOLUTION. THE CASE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. LATER REVIEW OF THE DATA FILES NOTED THAT FLOW WAS HIGHER THAN EXPECTED AND THERE WERE PRESSURE FLUCTUATIONS. LATER SERVICING WAS PERFORMED AND THE INJECTION PROPORTIONAL VALVE (MKS) WAS REPLACED, THE FLOW METER WAS ZEROED, AND THE PATIENT BOARD TEMPERATURES WERE CALIBRATED WHICH RESOLVED THE ISSUES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20047900 ↗
• InjuryJul 8, 2024Infusion or Flow Problem; Protective Measures Problem; Noise, Audible; Infusion or Flow Problem; Protective Measures Problem; Noise, Audible

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, MULTIPLE SYSTEM NOTICES WERE RECEIVED INDICATING THAT THE REFRIGERANT DELIVERY PATH WAS OBSTRUCTED. THE CONSOLE WAS REBOOTED, COAXIAL UMBILICAL CABLE AND BALLOON CATHETER REPLACED AND CONSOLE WAS VENTED WITHOUT RESOLVE. THE COAXIAL PORT WAS NOTED TO BE CLEAR. THE HIGH PRESSURE REGULATOR (HPR) VALUES WERE NOT AS EXPECTED. THE COAXIAL UMBILICAL CABLE WAS REPLACED AGAIN WITHOUT RESOLVE. THE FLOW WAS NOT AS EXPECTED DURING THE SYSTEM FLUSH. ADDITIONALLY, THERE WAS A CLICKING SOUND COMING FROM THEN NON-TANK SIDE DOOR. THE CASE WAS ABORTED, THE PATIENT WAS UNDER GENERAL ANESTHESIA. A SERVICE WAS RECOMMENDED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19687702 ↗
• InjuryApr 23, 2024Adverse 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 TEMPERATURES WERE LOWER THAN EXPECTED AND A FULL ABLATION WAS UNABLE TO BE COMPLETED. THE CONSUMABLES WERE RECONNECTED, THE TANK, COAXIAL UMBILICAL CABLE, AND ELECTRICAL UMBILICAL CABLE WERE REPLACED, AND THE AUTO CONNECTION BOX WAS BYPASSED WITHOUT RESOLUTION. THE CASE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE DATA FILES WERE LATER REVIEWED AND A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SYSTEM DETECTED A SOFTWARE ERROR AND STOPPED THE INJECTION. DURING A LATER SERVICING OF THE CONSOLE, THE TEMPERATURE AND POWER SUPPLY VOLTAGE WERE CALIBRATED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19169299 ↗
• InjuryMar 20, 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, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THERE WAS A PROBLEM WITH THE INJECTION PROCESS. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS UNDER GENERAL ANESTHESIA. TEST INJECTIONS WERE PERFORMED AND THE VENT VALVE WAS OPEN SO IT WAS THEN CLOSED. A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE BALLOON WAS DEFLATED. THE LOW PRESSURE REGULATOR (LPR) WAS NOT AS EXPECTED AND INFLATIONS WERE ABNORMAL. A SERVICING WAS PERFORMED REPLACING CONSUMABLES, CHECK VALVES, BLOOD BOTTLE, VALVE BOARD, AND BALLOON PANEL DID NOT RESOLVE THE ISSUE. ADDITIONAL PARTS WERE NEEDED TO REPAIR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16571818 ↗
• InjuryDec 6, 2022Adverse 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 CASE WAS ABORTED WHILTE 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 15926071 ↗
• InjuryJul 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THAT THE CASE WAS ABORTED AND 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 14985669 ↗
• InjuryMar 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use 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 COAXIAL AND ELECTRICAL UMBILICAL CABLES, ELECTROPHYSIOLOGY (EP) CATHETER, AND AUTO CONNECTION BOX WERE REPLACED BUT THE SYSTEM NOTICE PERSISTED. THE PROCEDURE WAS ABORTED UNDER GENERAL ANESTHESIA. A SERVICE VISIT OCCURRED ON A LATER DATE AND THE SYSTEM NOTICE WAS REPRODUCED AND THE FLOW AND PRESSURE WERE HIGHER THAN EXPECTED. THE INJECTION PROPORTIONAL VALVE WAS REPLACED AND THE FLOW METER WAS RECALIBRATED WHICH RESOLVED THE ISSUES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13638870 ↗
• InjuryNov 28, 2021Adverse Event Without Identified Device or Use Problem; Protective Measures Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Protective Measures Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A CRYOABLATION PROCEDURE, THE CASE WAS ABORTED AND 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 12880092 ↗
• InjuryNov 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE REFRIGERANT DELIVERY PATH WAS OBSTRUCTED. HE 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 12746669 ↗
• InjuryOct 4, 2021Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A BACKUP CONSOLE WAS USED AND THE SYSTEM NOTICE INDICATING THAT THE REFRIGERANT DELIVERY PATH WAS OBSTRUCTED, REOCCURRED. 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 12568491 ↗
• InjuryMar 30, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A CRYOABLATION PROCEDURE, THE CASE WAS ABORTED AND 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 11589694 ↗
• InjuryOct 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYOABLATION PROCEDURE DURING THE LAST THAW, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION. THE CASE CA WAS ABORTED ON THE LAST ABLATION AND THE PATIENT WAS UNDER GENERAL ANESTHESIA. TEST INFLATIONS WERE PERFORMED AFTER THE PROCEDURE USING THE SAME CONSUMABLES AND THE SYSTEM NOTICE DID NOT REPRODUCE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9178737 ↗
• MalfunctionJul 16, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A CRYOABLATION PROCEDURE, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SYSTEM DETECTED A HIGH LEVEL OF REFRIGERANT FLOW DURING THE SYSTEM FLUSH, AND THE SYSTEM FLUSH WAS STOPPED. THE CASE WAS ABORTED WITH THE PATIENT UNDER GENERAL ANESTHESIA. A FIELD SERVICE VISIT WAS COMPLETED ON A LATER DATE. PRESSURE OVERSHOOTS WERE OBSERVED AND A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED A HIGH LEVEL OF REFRIGERANT FLOW AND STOPPED THE INJECTION. THE INJECTION PROPORTION VALVE WAS REPLACED TO ADDRESS THE PRESSURE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8795601 ↗
• InjuryMay 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SYSTEM DETECTED A SOFTWARE ERROR AND STOPPED THE INJECTION. THE ELECTRICAL UMBILICAL CABLE WAS REPLACED WITHOUT RESOLVE. HOWEVER, AFTER CHECKING OTHER CONSUMABLES, THE NOTICE COULD BE CLEARED. IT WAS THEN REPORTED THAT A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED A COMPROMISED OUTER VACUUM. THE BALLOON CATHETER WAS REPLACED AND OTHER CONSUMABLES WERE RECONNECTED AND THE ELECTRICAL PINS WERE CHECKED WITHOUT RESOLVE. THE CASE WAS ABORTED AND THE PATIENT WAS UNDER GENERAL ANESTHESIA. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8654689 ↗
• InjuryDec 21, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  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 WITHOUT RESOLVE. IT WAS ALSO NOTED THAT THERE WAS NO FROSTING ON THE CATHETER SHAFT. TROUBLESHOOTING WAS DONE WITH TANK REPLACEMENT AND VENTING WITHOUT RESOLVE. PRESSURE WAS FLUCTUATING AT LOWER THAN OPTIMAL LEVELS BEFORE CUTTING OFF. THE CATHETER WAS REPLACED, AND A PRESSURE INCREASE WAS NOTED. THEN, THE COAXIAL UMBILICAL CABLE WAS REPLACED AGAIN, AND THE PRESSURE INCREASED AGAIN. A FOURTH COAXIAL UMBILICAL CABLE WAS USED, BUT FLOW AND PRESSURE WERE STILL NOT AT OPTIMAL LEVELS. ANOTHER SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE REFRIGERANT DELIVERY PATH WAS OBSTRUCTED. THE TANK WAS VENTED AGAIN BUT THE SYSTEM NOTICE PERSISTED. THE CASE WAS ABORTED, AND THE PATIENT WAS UNDER GENERAL ANESTHESIA. A FIELD SERVICE VISIT WAS SCHEDULED FOR A LATER DATE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ON 2017-12-19, 08:15:52: A FIELD SERVICE VISIT TOOK PLACE ON A LATER DATE AND THE CONSOLE WAS SERVICED AS APPROPRIATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7139797 ↗
• InjurySep 18, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  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, CATHETER, AND AUTO CONNECTION BOX WERE ALL REPLACED WITHOUT RESOLVE. THE SYSTEM WAS VENTED, AND THE CASE CONTINUED. HOWEVER, ANOTHER SYSTEM NOTICE WAS RECEIVED MULTIPLE TIMES INDICATING THAT THE BALLOON INFLATION PRESSURE WAS NOT REACHED IN TIME. THE CASE WAS ABORTED, AND THE PATIENT WAS UNDER GENERAL ANESTHESIA. A FIELD SERVICE VISIT TOOK PLACE ON A LATER DATE, AND THE CONSOLE WAS DE-INSTALLED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6872459 ↗
• InjuryMay 11, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A CRYOABLATION PROCEDURE, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED A HIGH LEVEL OF REFRIGERANT FLOW AND STOPPED THE INJECTION. IT WAS DETERMINED THAT THE SYSTEM NOTICE WAS RECEIVED DUE TO A BROKEN MKS VALVE. A FIELD SERVICE VISIT WAS SCHEDULED FOR A LATER DATE. THE CASE WAS ABORTED AND THE PATIENT WAS UNDER GENERAL ANESTHESIA. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6560643 ↗
• InjuryFeb 28, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  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 TEMPERATURES WERE NOT DROPPING PROPERLY. THE CASE ENDED UP BEING ABORTED AND THE PATIENT WAS UNDER GENERAL ANESTHESIA. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6365031 ↗

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.