NA 106A3 (UDI 00643169946644)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169946644), received between Jun 22, 2017 and Nov 17, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Infusion or Flow 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 17, 2025Infusion 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 LATER REPORTED THAT IT WAS AN EP CATHETER THAT WAS USE IN THE CRYO ABLATION PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23567530 ↗
• InjuryJun 2, 2022Appropriate 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 INJECTION WAS STOPPED BECAUSE THE CRYOMAPPING TEMPERATURE EXCEEDED THE PRESET VALUE BY MORE THAN FIFTEEN DEGREES. THE ELECTRICAL UMBILICAL CABLE WAS RECONNECTED MULTIPLE TIMES 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 14578133 ↗
• InjuryApr 17, 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 REFRIGERANT DELIVERY PATH WAS OBSTRUCTED. THE COAXIAL UMBILICAL CABLE WAS RECONNECTED WITHOUT RESOLVE. THE TANK, VACUUM AND AIRWAY WERE CHECKED. THE COAXIAL UMBILICAL CABLE, ELECTRICAL UMBILICAL CABLE, AND AUTO CONNECTION BOX WERE REPLACED WITHOUT RESOLVE. THE CONSOLE WAS REBOOTED, THE GAS WAS VENTED, AND THE TANK REPLACED, WITHOUT RESOLVE. THE BALLOON CATHETER WAS THEN REPLACED WITHOUT RESOLVE. THE PROCEDURE 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 8525002 ↗
• InjuryMar 1, 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 SYSTEM SELF-TEST DID NOT PASS. THE CONSOLE WAS REBOOTED MULTIPLE TIMES WITHOUT RESOLVE. THE SCAVENGING AND VACUUM LINES WERE DISCONNECTED AND RECONNECTED WITHOUT RESOLVE. THE CASE OUTCOME IS UNKNOWN. A FIELD SERVICE VISIT WAS RECOMMENDED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. INCOMING INFORMATION INDICATED THAT THE CONSOLE WAS UNINSTALLED AND REPLACED. ADDITIONAL INFORMATION INDICATED THE CASE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. INCOMING INFORMATION INDICATED FIELD SERVICE TOOK PLACE TO NO AVAIL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7307803 ↗
• InjuryJun 22, 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 BALLOON INFLATION PRESSURE WAS NOT REACHED IN TIME. RECONNECTED CABLES WITHOUT RESOLVE. IT WAS NOTED THE LOW PRESSURE REGULATOR (LPR) WAS NOT WITHIN THE EXPECTED RANGE. THE SYSTEM WAS VENTED AND ANOTHER SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE BALLOON INFLATION PRESSURE WAS NOT REACHED IN TIME. THE CASE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. A FIELD SERVICE VISIT WAS RECOMMENDED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6661363 ↗

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.