NA 106A3 (UDI 00643169279063)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00643169279063), received between May 12, 2017 and Oct 11, 2023 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Protective Measures Problem” (1 report).

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryOct 11, 2023Adverse 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, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SYSTEM WAS NOT READY. THE CONSOLE WAS REBOOTED WITHOUT RESOLUTION. THE CONSOLE WAS THEN REBOOTED WITH EVERYTHING DISCONNECTED WITHOUT RESOLUTION. THE TEMPERATURE OF THE SUB-COOLER WAS NOTED TO BE TOO WARM, PREVENTING THE CONSOLE FROM BEING USED. THE CASE WAS SUBSEQUENTLY 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 17914777 ↗
• InjuryFeb 2, 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 FLUID IN THE CATHETER AND STOPPED THE INJECTION. THE COAXIAL UMBILICAL CABLE WAS REPLACED WITHOUT RESOLUTION. 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 13426062 ↗
• InjuryNov 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYOABLATION PROCEDURE, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE REFRIGERANT DELIVERY PATH WAS OBSTRUCTED AND A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SYSTEM WAS NOT READY. THE CONSOLE WAS REBOOTED AND COAXIAL UMBILICAL CABLE AND BALLOON CATHETER REPLACED WITHOUT RESOLUTION. THE TANK WAS THEN EXCHANGED BUT THE SYSTEM NOTICES PERSISTED. THE CASE WAS ABORTED WITH 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 12893892 ↗
• InjuryNov 18, 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, THE PATIENT WAS UNDER GENERAL ANESTHESIA AND THE CASE WAS ABORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12839973 ↗
• InjuryAug 27, 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. THE TANK WAS REPLACED AND WAS VENTED TWICE WITHOUT RESOLUTION. 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 12380442 ↗
• MalfunctionFeb 5, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A BURNING SMELL WAS NOTED COMING FROM THE CONSOLE. IT WAS NOTED THE SMELL WAS STRONGER ON THE SIDE OF THE CONSOLE THAT CONTAINED THE SUB COOLER. TEST INJECTIONS WERE RAN AND A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SYSTEM WAS NOT READY. THE CASE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. A SERVICE VISIT LATER TOOK PLACE AND THE SUB COOLER WAS REPLACED WITH RESOLVE, AND THE CONSOLE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8308651 ↗
• InjuryNov 22, 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 VACUUM WAS DISABLED DUE TO A PROBLEM WITH THE COAXIAL UMBILICAL CABLE. THE COAXIAL UMBILICAL CABLE AND ELECTRICAL UMBILICAL CABLE WERE REPLACED WITHOUT RESOLVE. IT WAS THEN INDICATED THAT THE HIGH BASELINE FLOW ICON DISPLAYED ON THE CONSOLE. THE COAXIAL UMBILICAL CABLE WAS RECONNECTED, THE COAXIAL CAP WAS RECONNECTED, THE VACUUM WAS DISABLED, ALL 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 7054397 ↗
• InjuryJun 8, 2017Appropriate 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 SAFETY SYSTEM DETECTED A HIGH LEVEL OF REFRIGERANT FLOW AND STOPPED THE INJECTION. ADDITIONALLY, TEMPERATURE ISSUES WERE OBSERVED. THE COAXIAL UMBILICAL CABLE WAS EXCHANGED TWICE WITH NO RESOLVE. IT WAS ALSO NOTED THAT FLOW AND PRESSURE WERE FLUCTUATING. THE ELECTROPHYSIOLOGY (EP) CATHETER WAS THEN REPLACED WITHOUT RESOLVE. ADDITIONALLY, THE REFRIGERANT TANK WAS CLOSED AND REOPENED, HOWEVER, TEMPERATURES WERE STILL NOT DROPPING DESPITE TARGET FLOW RANGE BEING MET. THE TANK WAS THEN REPLACED WITHOUT RESOLVE. ALSO, THE PHYSICIAN WAS ABLE TO OBTAIN GOOD TEMPERATURES WHEN ABLATING IN A SALINE BATH WITH THE SAME CONSUMABLES. THE CASE WAS ABORTED AND THE PATIENT WAS UNDER GENERAL ANESTHESIA. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. TEST INJECTIONS WERE PERFORMED ON THE CONSOLE AND A SYSTEM NOTICE WAS RECEIVED MULTIPLE TIMES INDICATING THAT THE OPERATIONAL TEMPERATURE OF THE SYSTEM WAS HIGH, PREVENTING PROPER OPERATION. A FIELD SERVICE VISIT WAS SCHEDULED FOR A LATER DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6622937 ↗
• InjuryMay 29, 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 AFTER POWERING ON THE CONSOLE, INDICATING THAT THE SAFETY SYSTEM DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION. TROUBLESHOOTING ATTEMPTS, INCLUDING REPLACING THE AUTO CONNECTION BOX AND CATHETER WERE TAKEN 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 6597120 ↗
• InjuryMay 12, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, MULTIPLE SYSTEM NOTICES HAD OCCURRED INDICATING THAT THE REFRIGERANT DELIVERY PATH WAS OBSTRUCTED. THE BALLOON CATHETER, COAXIAL UMBILICAL CABLE WERE REPLACED AND THE CONSOLE WAS VENTED WITHOUT RESOLVE. THE PROCEDURE 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 6563173 ↗

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.