NA 106A3 (UDI 00643169983892)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169983892), received between Oct 19, 2022 and Sep 5, 2024 — classified as 2 injuries, 1 malfunction.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 5, 2024Infusion 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 SAFETY SYSTEM DETECTED A HIGH LEVEL OF REFRIGERANT FLOW AND STOPPED THE INJECTION. THE BALLOON CATHETER , COAXIAL UMBILICAL CABLE AND TANK WERE REPLACED WITHOUT RESOLVE. THE CASE WAS ABORTED THE PATIENT WAS UNDER GENERAL ANESTHESIA. A SERVICE WAS RECOMMENDED. DATA FILES WERE REVIEWED AND PRESSURE WAS NOT AS EXPECTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20144976 ↗
• InjuryAug 27, 2024Adverse Event Without Identified Device or Use Problem; Temperature Problem; Adverse Event Without Identified Device or Use Problem; Temperature Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THERE WAS NO LIMIT TO THE TEMPERATURE, AND IT DECREASED UNEXPECTEDLY. THE BALLOON CATHETER AND COAXIAL UMBILICAL CABLE WERE REPLACED WITHOUT RESOLVE. THE CASE WAS ABORTED. 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 20075546 ↗
• MalfunctionOct 19, 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 REFRIGERANT DELIVERY PATH WAS OBSTRUCTED. THE PRESSURE AND FLOW WERE DECREASING. THE COAXIAL UMBILICAL CABLE WAS REPLACED WITHOUT RESOLVING THE ISSUES. THE HIGH PRESSURE REGULATOR WAS RISING. THE PROCEDURE 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 15632926 ↗

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.