NA 106A3 (UDI 00643169449596)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00643169449596), received between Jan 26, 2017 and Feb 17, 2026 — classified as 18 injuries.

The most frequently reported specific device problem is “Material Integrity Problem” (2 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem; Protective Measures Problem

  ADDITIONAL INFORMATION INDICATED THAT THE PATIENTS HOSPITALIZATION WAS ROUTINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24362553 ↗
• InjuryOct 1, 2022Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Protective Measures Problem; Temperature Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Protective Measures Problem; Temperature Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE SCREEN ON THE CONSOLE WAS FROZEN. THE CONSOLE WAS REBOOTED SEVERAL TIMES, BUT THE ISSUE PERSISTED. UPON START UP, A "NO INPUT DETECTED" MESSAGE WAS RECEIVED. THE POWER SOURCE WAS SWITCHED FROM A SHARED OUTLET TO A DEDICATED OUTLET, AND THE MESSAGE RESOLVED. IT WAS THEN REPORTED THAT TEMPERATURES WERE BOUNCING AROUND UNEXPECTEDLY. THE AUTO CONNECTION BOX WAS REPLACED, BUT THE ISSUE PERSISTED. ONCE THE CATHETER WAS CONNECTED , A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED A COMPROMISED OUTER VACUUM. FOLLOWING THE REPLACEMENT OF THE ELECTRICAL UMBILICAL CABLE AND BALLOON CATHETER, THE CONSOLE WOULD NOT PASS THE SYSTEM INTEGRITY TEST. THE COAXIAL UMBILICAL CABLE WAS ALSO REPLACED BUT THE SCREEN CONTINUED TO FREEZE UPON REBOOT ATTEMPTS AND BEGAN TO BLACK OUT INTERMITTENTLY. DESPITE REBOOT ATTEMPTS WITH THE CONSUMABLES BEING BOTH CONNECTED AND DISCONNECTED, THE ISSUES PERSISTED. OCCLUSION OF THE LEFT SUPERIOR PULMONARY VEIN (LSPV) WAS ACHIEVED; HOWEVER, DUE TO THE PERSISTING ISSUES, THE CASE WAS ULTIMATELY ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15525650 ↗
• InjurySep 1, 2022Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN EMPLOYEE OF THE FACILITY OPENED THE TANK WHEN IT WAS NOT CONNECTED INSIDE THE CONSOLE.  THE EMPLOYEE WAS ATTEMPTING TO CHANGE THE TANK. THE EMPLOYEE SUSTAINED AN INJURY TO THEIR HAND AND WENT TO THE EMPLOYEE HEALTH CENTER. THE EMPLOYEE HAD FIRST DEGREE BURNS ON THEIR HAND. CREAM WAS APPLIED TO THE BURN AND THE HAND WAS WRAPPED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15334465 ↗
• InjuryDec 5, 2020Appropriate 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. ADDITIONAL ABLATIONS WERE ATTEMPTED WITHOUT RESOLVING THE ISSUE. THE COAXIAL AND ELECTRICAL UMBILICAL CABLES, AND BALLOON CATHETER WERE REPLACED WITHOUT RESOLVING THE ISSUE. 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 10953463 ↗
• InjurySep 29, 2020Material Integrity Problem; Appropriate Device Problem Term/Code Not Available; Noise, Audible; Material Integrity Problem; Appropriate Device Problem Term/Code Not Available; Noise, Audible

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THERE WAS A PROBLEM WITH THE REFRIGERANT PORT. THE CONSOLE WAS ALSO LETTING OUT A "HISSING NOISE". THE CONSOLE WAS REBOOTED, COAXIAL PORT CHECKED, AND SCAVENGING LINE RECONNECTED MULTIPLE TIMES AND THE NOTICE COULD NOT BE CLEARED. THEN, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THERE IS A PROBLEM WITH THE SYSTEM. THE CASE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. A SERVICE VISIT TOOK PLACE AT A LATER DATE AND THE "WATCHDOG BOARD" WAS REPLACED WHICH RESOLVED THE ISSUES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10602146 ↗
• InjuryJul 10, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  INCOMING INFORMATION INDICATED THAT A SERVICE VISIT TOOK PLACE ON A LATER DATE. THE COAXIAL CAP WAS REPLACED AND THE CONSOLE WAS SERVICED AS APPROPRIATE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10257476 ↗
• InjuryFeb 25, 2020Adverse 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 THERE WAS A PROBLEM WITH THE REFRIGERANT PORT. THE CONSOLE WAS REBOOTED WITHOUT RESOLUTION. A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THERE IS A PROBLEM WITH THE SYSTEM. SUCTION WAS OBSERVED WHEN THE COAXIAL UMBILICAL CABLE WAS REMOVED FROM THE CONSOLE. ALSO, AN ABNORMAL PRESSURE WAS OBSERVED. SO, THE SYSTEM WAS VENTED, AND THE COAXIAL CAP WAS REMOVED WITHOUT RESOLUTION. THE SYSTEM WAS REBOOTED AGAIN WHICH APPEARED TO RESOLVE THE ISSUE WITH THE PRESSURE AT THE TIME. HOWEVER, THE PRESSURE REAPPEARED AGAIN, AND, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THERE WAS A PROBLEM WITH THE REFRIGERANT PORT ONCE AGAIN. THE CASE WAS ABORTED WITH THE PATIENT UNDER GENERAL ANESTHESIA. A SERVICE VISIT TOOK PLACE AT A LATER DATE AND THE CONSOLE WAS SERVICED AS APPROPRIATE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9750968 ↗
• InjuryFeb 13, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, SYSTEM NOTICES WERE RECEIVED INDICATING THAT THE REFRIGERANT DELIVERY PATH WAS OBSTRUCTED. THE COAXIAL UMBILICAL CABLE AND BALLOON CATHETER WERE REPLACED WITHOUT RESOLVE. THE COAXIAL PORT WAS EXAMINED, AND NO DEBRIS OR BROKEN TIP WAS OBSERVED. THE TANK WAS REPLACED AND THE CONSOLE VENTED, WITHOUT RESOLVE. THE COAXIAL UMBILICAL CABLE WAS REPLACED AGAIN AND THE CONSOLE WAS REBOOTED. NO FLOW WAS NOTED, AND THE PRESSURE WAS DIFFERENT THAN EXPECTED. THE CASE WAS ABORTED WITH THE PATIENT 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 9708387 ↗
• InjuryJan 6, 2020Adverse 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 THERE IS A PROBLEM WITH THE SYSTEM. THE CONSOLE WAS REBOOTED FOUR TIMES WITH THE SAME SYSTEM NOTICE. THE SCAVENGING HOSE WAS DISCONNECTED FROM THE CONSOLE AND THE SYSTEM WAS REBOOTED. HOWEVER, THE SYSTEM NOTICE WAS STILL PERSISTENT AND THEN A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THERE WAS A PROBLEM WITH THE REFRIGERANT PORT. ADDITIONALLY, PRESSURE/FLOW ISSUES WERE OBSERVED DURING THE CASE. THE CASE WAS ABORTED AND THE PATIENT WAS UNDER GENERAL ANESTHESIA. A FIELD SERVICE VISIT WAS RECOMMENDED AS A RESULT OF THIS EVENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9551243 ↗
• InjuryJul 3, 2019Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION. THE COAXIAL UMBILICAL CABLE, ELECTRICAL UMBILICAL CABLE AND ELECTROPHYSIOLOGY (EP) CATHETER WERE REPLACED, AND THE CONSOLE WAS REBOOTED, WITHOUT RESOLVE. ANOTHER SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION. THE SAME PRODUCTS WERE REPLACED WITHOUT RESOLVE. THE CASE WAS ABORTED WITH THE PATIENT UNDER GENERAL ANESTHESIA. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8760423 ↗
• InjuryNov 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE FLOW WAS NOT WITHIN THE EXPECTED RANGE, THEN A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE REFRIGERANT DELIVERY PATH WAS OBSTRUCTED. THE COAXIAL UMBILICAL CABLE WAS RECONNECTED WITHOUT RESOLVE. THE COAXIAL UMBILICAL CABLE WAS REPLACED WITHOUT RESOLVE. IT WAS NOTED THAT NO DEBRIS WAS SEEN IN THE COAXIAL PORT. THE TANK WAS REPLACED WITHOUT RESOLVE. THE BALLOON CATHETER WAS REPLACED WITHOUT RESOLVE. THE CASE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION REPORTED THAT A FIELD SERVICE VISIT TOOK PLACE ON A LATER DATE, THE FLOW METER WAS OUT OF TOLERANCE AND IT WAS ADJUSTED. THE CONSOLE WAS SERVICED AS APPROPRIATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8096909 ↗
• InjurySep 21, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, AFTER THE FIRST FULL INJECTION, A SECOND INFLATION WAS ATTEMPTED. THE BALLOON DID NOT INFLATE, AND A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE BALLOON WAS NOT SUFFICIENTLY INFLATED. THE BALLOON CATHETER WAS REPLACED WITHOUT RESOLUTION. THE LOW-PRESSURE REGULATOR (LPR) WAS CHECKED AND IT WAS OUT OF TOLERANCE. THE SYSTEM WAS VENTED WITHOUT RESOLUTION. 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 7898960 ↗
• InjurySep 19, 2018Appropriate 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 BALLOON WAS NOT SUFFICIENTLY INFLATED. THE COAXIAL UMBILICAL CABLE, CATHETER AND TANK WERE REPLACED WITHOUT RESOLVE. IT WAS NOTED THAT THE LOW PRESSURE REGULATOR (LPR) WAS NOT WITHIN THE EXPECTED RANGE. THE CASE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. A FIELD SERVICE VISIT TOOK PLACE ON A LATER DATE AND THE CONSOLE WAS SERVICED AS APPROPRIATE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7891310 ↗
• InjuryAug 9, 2018Adverse 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 BALLOON WAS NOT SUFFICIENTLY INFLATED. TROUBLE SHOOTING WAS ATTEMPTED; THE COAXIAL UMBILICAL, ELECTRICAL UMBILICAL AND CATHETER WERE ALL REPLACED WITHOUT RESOLVE. ADDITIONALLY, THE LOW-PRESSURE REGULATOR (LPR) DID NOT READ A VALUE. 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 Known Impact Or Consequence To Patient

  MAUDE report 7768930 ↗
• InjuryMay 22, 2018Adverse 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, THE TEMPERATURE WAS NOT AS EXPECTED. ADDITIONALLY, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE REFRIGERANT DELIVERY PATH WAS OBSTRUCTED. THE ERROR WAS ATTEMPTED TO BE CLEARED WITHOUT RESOLVE. THE COAXIAL UMBILICAL CABLE WAS RECONNECTED SEVERAL TIMES WITHOUT RESOLVE. THE ELECTRICAL UMBILICAL CABLE WAS REPLACED, ALL CONNECTIONS WERE CHECKED, AND THE CONSOLE WAS RESTARTED, WITH NO SUCCESS. THE CATHETER WAS ALSO TESTED OUT OF THE PATIENT BODY WITH NO RESOLVE. THE PROCEDURE WAS ABORTED DUE TO IMPOSSIBILITY OF CONSOLE OPERATION, 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 7534179 ↗
• InjuryOct 3, 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 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 Known Impact Or Consequence To Patient

  MAUDE report 6911301 ↗
• InjuryJun 26, 2017Adverse 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 MULTIPLE TIMES INDICATING THAT THERE IS A PROBLEM WITH THE SYSTEM. THE CONSOLE WAS REBOOTED WITH RESOLVE. ADDITIONALLY, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE PRESSURE WAS LOW IN THE SYSTEM. THE TANK WAS REPLACED. THE SYSTEM WAS VENTED AND CONSOLE WAS REBOOTED WITHOUT RESOLVE. 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 SERVICED AS APPROPRIATE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6666954 ↗
• InjuryJan 26, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING TO A CRYO ABLATION PROCEDURE, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE REFRIGERANT DELIVERY PATH WAS OBSTRUCTED. THE TANK, COAXIAL UMBILICAL CABLE AND THE CATHETER WERE ALL REPLACED WITHOUT RESOLVE. THE PROCEDURE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. A SERVICE REQUEST WAS SCHEDULED AND THE CONSOLE WAS SERVICED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6279344 ↗

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.