NA 106A3 (UDI 00643169203150)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169203150), received between Nov 10, 2017 and Oct 30, 2023 — classified as 6 injuries.

The most frequently reported specific device problem is “Protective Measures 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 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 FLUID IN THE CATHETER AND STOPPED THE INJECTION. THE ELECTROPHYSIOLOGY (EP) CATHETER WAS REPLACED WITHOUT RESOLVE. THE COAXIAL UMBILICAL CABLE AND COAXIAL PORT WERE INSPECTED AND NO BLOOD OR FLUID WAS NOTED. THE ELECTRICAL UMBILICAL CABLE WAS REPLACED WITHOUT RESOLVE. THE AUTO CONNECTION BOX WAS REPLACED WITHOUT RESOLVE. THE CONSOLE WAS SWITCHED TO ANOTHER OUTLET WITHOUT RESOLVE. THE BEAR HUGGER WAS TURNED OFF 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18034339 ↗
• InjuryJun 2, 2023Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Protective Measures Problem; Mechanical 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 IS A PROBLEM WITH THE SYSTEM. THE CONSOLE WAS REBOOTED SEVERAL TIMES WITHOUT RESOLUTION. ON THE SERVICE SYSTEM SCREEN, THE TANK WEIGHT WAS FLUCTUATING UNEXPECTEDLY. THE TANK WAS SEATED CORRECTLY. THE TANK WAS OPENED AND THEN CLOSED, BUT THE TANK WEIGHT NEVER STABILIZED. THE CASE 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 17050763 ↗
• InjuryMay 16, 2019Appropriate 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 DEFLATED. THEN, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THERE WAS A PROBLEM WITH THE REFRIGERANT PORT. THE CONSOLE WAS REBOOTED. IT WAS THEN INDICATED THAT FROST WAS OBSERVED ON THE PORT. A SYSTEM NOTICE WAS THEN RECEIVED INDICATING THAT THERE IS A PROBLEM WITH THE SYSTEM. EVERYTHING WAS DISCONNECTED FROM THE CONSOLE WITHOUT RESOLVE. RECONNECTING THE HOSPITAL ADAPTER RESOLVED THE SECOND SYSTEM NOTICE. ADDITIONALLY, A HISSING WAS HEARD FROM THE CONSOLE. THE CONSOLE WAS REBOOTED AGAIN AND THE CATHETER RETRACTED BACK IN THE SHAFT AFTER SOME DIFFICULTY. A FIELD SERVICE VISIT TOOK PLACE ON A LATER DATE. THE COAXIAL CAP WAS FOUND TO BE DAMAGED AND THE CONSOLE WAS SERVICED AS APPROPRIATE. THE CASE WAS ABORTED AS THERE WAS A LEAK IN THE CONSOLE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION REPORTED THAT THE PATIENT WAS UNDER GENERAL ANESTHESIA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8617246 ↗
• InjuryFeb 20, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE LOW PRESSURE REGULATOR (LPR) WAS NOT AS EXPECTED. ADDITIONALLY, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SYSTEM DETECTED AN ELECTRICAL COMPONENT FAILURE. THE ELECTRICAL PATH WAS DISCONNECTED AND RECONNECTED WITH RESOLVE. ADDITIONALLY, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE BALLOON WAS NOT SUFFICIENTLY INFLATED. THE COAXIAL UMBILICAL CABLE AND BALLOON CATHETER WERE REPLACED WITHOUT RESOLVE. IT WAS ALSO REPORTED THAT PRESSURE WAS NOT AS EXPECTED. A FIELD SERVICE VISIT WAS RECOMMENDED. THE CASE WAS ABORTED, AND THE PATIENT WAS UNDER GENERAL ANESTHESIA. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ON 2018-02-12: INFORMATION INDICATED THAT A FIELD SERVICE VISIT TOOK PLACE AND THE POWER SUPPLY VOLTAGE WAS OUT OF TOLERANCE. THE CONSOLE WAS SERVICED AS APPROPRIATE. THE PRODUCT ISSUE REPORTED IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY; HOWEVER, THE RISK OF THE PATIENT BEING UNDER GENERAL ANESTHESIA WITHOUT FULL THERAPEUTIC EFFECT IS THE ADVERSE EVENT BEING REPORTED. THE DECISION TO ABORT THE PROCEDURE WITHOUT USE OF ALTERNATE THERAPY WAS BASED UPON THE MEDICAL JUDGME

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7284351 ↗
• InjuryNov 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 SAFETY SYSTEM DETECTED A HIGH LEVEL OF REFRIGERANT FLOW AND STOPPED THE INJECTION, AND 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 CONSOLE WAS REBOOTED AND THE COAXIAL UMBILICAL CABLE AND BALLOON CATHETER WERE REPLACED, ALL WITHOUT RESOLVE. IT WAS ALSO REPORTED THAT THE TEMPERATURE DROPPED RAPIDLY AND THE PRESSURE VALUES WERE DISPLAYING ABNORMAL BEHAVIOR, INCLUDING OVERSHOOTS. 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 7051809 ↗
• InjuryNov 10, 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 BALLOON CATHETER, AND COAXIAL UMBILICAL CABLE WERE REPLACED WITHOUT RESOLVE. THE TANK WAS REPLACED WITHOUT RESOLVE. THE SYSTEM WAS VENTED 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.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7017542 ↗

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.