NA 106A3 (UDI 00763000486778)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000486778), received between Dec 25, 2023 and May 14, 2025 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2025Adverse 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, AN ERROR MESSAGE WAS RECEIVED INDICATING THAT THERE WAS A SERIAL PERIPHERAL INTERFACE (SPI) CIRCULAR REDUNDANCY CHECK ERROR. THE CASE WAS ABORTED WHILE THE PATIENT WAS UNDER DEEP SEDATION AND/OR GENERAL ANESTHESIA. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22022601 ↗
• InjuryJan 26, 2024Adverse 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 A HIGH LEVEL OF REFRIGERANT FLOW AND STOPPED THE INJECTION. THE ISSUE WAS UNABLE TO BE RESOLVED AND THE PROCEDURE WAS ABORTED. IT IS UNKNOWN WHETHER THE PATIENT WAS UNDER GENERAL ANESTHESIA. A HIGH LEVEL OF PHYSICIAN FRUSTRATION WAS NOTED. DURING A LATER SERVICING, AN ATYPICAL INJECTION PROPORTIONAL VALVE (MKS) FAILURE WAS OBSERVED. THE MKS AND VALVE BOARD WERE REPLACED WHICH RESOLVED THE ISSUES. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18592063 ↗
• InjuryDec 25, 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 SYSTEM DETECTED A HIGH LEVEL OF REFRIGERANT FLOW DURING THE SYSTEM FLUSH, AND THE SYSTEM FLUSH WAS STOPPED. ADDITIONALLY, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED A HIGH LEVEL OF REFRIGERANT FLOW AND STOPPED THE INJECTION. THE COAXIAL UMBILICAL CABLE WAS REPLACED AND THE ISSUE REMAINED. THE CASE WAS ABORTED AND THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE FAILURE FILES WERE REVIEWED AND CONFIRMED THE SYSTEM NOTICE INDICATING THAT THE SAFETY SYSTEM DETECTED A HIGH LEVEL OF REFRIGERANT FLOW AND STOPPED THE INJECTION. IT WAS ALSO NOTED THAT A SYSTEM NOTICE WAS RECEIVED ONCE INDICATING THAT THE REFRIGERANT DELIVERY PATH WAS OBSTRUCTED. AFTER THE CASE,TEST INJECTIONS WERE PERFORMED USING A FOCAL CATHETER. A FEW SUCCESSFUL ABLATIONS WERE PERFORMED AND THEN A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED A HIGH LEVEL OF REFRIGERANT FLOW AND STOPPED THE INJECTION. A FEW TEST INJECTIONS WERE PERFORMED USING A BALLOON CATHETER. THE DATA FILES WERE ANALYZED AND CONFIRMED SYSTEM NOTICES A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18390524 ↗

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.