Freezor™ Xtra 217F1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000542092), received between Mar 28, 2023 and Mar 28, 2023 — classified as 1 malfunction.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionMar 28, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, MULTIPLE SYSTEM NOTICES WERE RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED A HIGH LEVEL OF REFRIGERANT FLOW AND STOPPED THE INJECTION. THE COAXIAL UMBILICAL CABLE WAS DISCONNECTED AND RECONNECTED WHICH DID NOT RESOLVE THE ISSUE. THE CATHETER WAS REPLACE TWICE AND THE ISSUE REMAINED. THE COAXIAL UMBILICAL CABLE, AUTO CONNECTION BOX AND ELECTRICAL UMBILICAL CABLE WERE REPLACED WHICH DID NOT RESOLVE THE ISSUE. IT WAS VERIFIED THAT THE TANK WAS OPENED AND HAD SUFFICIENT GAS FOR THE CASE. THE CASE WAS SWITCHED TO RADIOFREQUENCY.  THE PATIENT REMAINED HEMODYNAMICALLY STABLE DURING THE ENTIRE CASE. THE CASE WAS COMPLETED WITH RADIOFREQUENCY. THE BIN FILES WERE REVIEWED AND THERE WERE NO PRESSURE OVERSHOOTS. TEST INJECTIONS WERE PERFORMED AFTER THE CASE AND IT APPEARED THAT THE CONSOLE WAS CONTROLLING PRESSURE AND FLOW IN THE EXPECTED RANGES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16632467 ↗

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.