NA 2037A (UDI 00643169496095)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169496095), received between Jan 29, 2024 and Jan 29, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Protective Measures 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 29, 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 THERE IS A PROBLEM WITH THE SYSTEM. THE CONSOLE WAS REBOOTED MULTIPLE TIMES, BUT THE ISSUE PERSISTED. THE AUTO CONNECTION BOX WAS REPLACED AND THE SYSTEM NOTICE RESOLVED. A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED BLOOD IN THE CATHETER HANDLE, THE INJECTION WAS STOPPED AND THE VACUUM DISABLED. THE AUTO CONNECTION BOX WAS SWITCHED BACK TO THE FIRST AUTO CONNECTION BOX AND THE SYSTEM NOTICE RESOLVED, BUT ABLATIONS COULD NOT BE PERFORMED. THE CASE WAS ABORTED. THE PATIENT WAS UNDER GENERAL ANESTHESIA. TEST ABLATIONS WERE PERFORMED AND A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE BALLOON INFLATION PRESSURE WAS NOT REACHED IN TIME. IT WAS ALSO REPORTED THAT A SYSTEM NOTICE WAS RECEIVED WITH THE FIRST AUTO CONNECTION BOX, INDICATING THAT THE SAFETY SYSTEM DETECTED BLOOD IN THE CATHETER HANDLE, THE INJECTION WAS STOPPED AND THE VACUUM DISABLED. DATA FILES COULD NOT BE OPENED FOR REVIEW. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18602555 ↗

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.