NA 106A3 (UDI 00643169195844)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169195844), received between Oct 24, 2022 and Mar 21, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Protective Measures Problem” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 21, 2023Infusion or Flow Problem; Adverse Event Without Identified Device or Use Problem; Infusion or Flow Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE CONSOLE WOULD NOT HOLD PRESSURE IN THE BALLOON. THE CASE WAS ABORTED 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 16581942 ↗
• InjuryDec 29, 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 REFRIGERANT DELIVERY PATH WAS OBSTRUCTED.  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 16068480 ↗
• InjuryOct 26, 2022Infusion or Flow Problem; Protective Measures Problem; Infusion or Flow Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE REFRIGERANT DELIVERY PATH WAS OBSTRUCTED. ADDITIONALLY, THE LOW PRESSURE REGULATOR (LPR) AND HIGH PRESSURE REGULATOR (HPR) VALUES WERE NOT AS EXPECTED. THE COAXIAL UMBILICAL CABLE AND BALLOON CATHETER WERE REPLACED WITHOUT RESOLUTION. ALSO, THE CONSOLE WAS VENTED WITHOUT RESOLUTION. THE CASE WAS ABORTED UNDER GENERAL ANESTHESIA. SERVICE WAS PERFORMED AT A LATER DATE. THE LOW PRESSURE REGULATOR (LPR) AND HIGH PRESSURE REGULATOR (HPR) WERE ADJUSTED WHICH RESOLVED THE ISSUE. THE NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15677128 ↗
• InjuryOct 24, 2022Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Protective Measures Problem; Noise, Audible; Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Protective Measures Problem; Noise, Audible

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, OBSTRUCTION NOISES WERE NOTED. THE TANK WAS OPENED AND THE BALLOON CATHETER, COAXIAL UMBILICAL CABLE WERE REPLACED WITHOUT RESOLVE. THE BALLOON CATHETER WAS REPLACED AGAIN WITHOUT RESOLVING THE NOISES. THE TANK WAS VENTED WITHOUT RESOLUTION. THE TANK WAS REPLACED A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE REFRIGERANT DELIVERY PATH WAS OBSTRUCTED. IT WAS FURTHER REPORTED THAT THE CASE WAS CANCELLED. THE PATIENT WAS UNDER GENERAL ANESTHESIA WHEN THE CASE WAS CANCELLED. A SERVICE VISIT WAS RECOMMENDED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15657475 ↗

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.