Freezor® Xtra 227F3Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169672475), received between Sep 13, 2018 and Nov 17, 2021 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (2 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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2021Material Integrity Problem; Material Integrity Problem

  AFTER A COMPLETED CASE, THE ELECTROPHYSIOLOGY (EP) CATHETER TESTED OUT OF SPECIFICATION PER THE MANUFACTURER'S INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12829989 ↗
• MalfunctionDec 6, 2020Fracture; Material Integrity Problem; Protective Measures Problem; Fracture; Material Integrity Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE STEERABILITY OF THE ELECTROPHYSIOLOGY (EP) CATHETER WAS NOT AS EXPECTED. IN AN ATTEMPT TO STRAIGHTEN OUT THE EP CATHETER, THE TIP OF THE CATHETER BROKE OFF AND 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 BROKEN TIP REMAINED IN THE SHEATH DURING REMOVAL. THE CASE WAS ABORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10955752 ↗
• InjuryJun 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE PATIENT EXPERIENCED AN ATRIOVENTRICULAR (AV) BLOCK. THE ELECTROPHYSIOLOGY (EP) CATHETER CONTINUED TO APPLY THERAPY AFTER ATTEMPTING TO STOP THE ABLATION WITH THE FOOT PEDAL. THE CABLES WERE DISCONNECTED FROM THE CONSOLE IN AN ATTEMPT TO STOP THE ABLATION. THE CASE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. AFTER MONITORING THE INTERMITTENT AV BLOCK, THE PATIENT WAS IMPLANTED WITH A PACEMAKER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Exit Block

  MAUDE report 8729161 ↗
• MalfunctionSep 13, 2018Device Contamination with Body Fluid; Device Contamination with Body Fluid

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION. ADDITIONALLY, IT WAS OBSERVED THAT THERE WAS BLOOD ON THE COAXIAL UMBILICAL CABLE. BOTH COAXIAL CABLE AND THERAPY CATHETER WERE REPLACED WITH RESOLVE. IT WAS ALSO REPORTED THAT A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SYSTEM DETECTED A SOFTWARE ERROR AND STOPPED THE INJECTION. THE CONTINUE BUTTON WAS PRESSED WITH RESOLVE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7874669 ↗

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.