Freezor™ Xtra 217F3Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00763000542108), received between Nov 17, 2022 and Apr 8, 2026 — classified as 5 injuries, 2 malfunctions.

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. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryApr 8, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, N-002 SYSTEM NOTICE OCCURRED. THE USER WAS UNABLE TO REMOVE THE COAX CAP AT THE TIME OF THE CALL, WHICH PREVENTED VERIFICATION OF A POSSIBLE COAX PORT OBSTRUCTION. THE CASE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. IT WAS REPORTED THAT 12 OF 14 ABLATION APPLICATIONS WERE ¿PERFECT,¿ AND THE N-002 OCCURRED ON APPLICATIONS 13 AND 14. A SUBSEQUENT INSPECTION FOUND THE COAX PORT TO BE CLEAR OF OBSTRUCTIONS, AND PHM RECORDS WERE RECEIVED AND REVIEWED. TEST ABLATIONS WERE REQUESTED/PERFORMED, DURING WHICH A FAULTY AUTO CONNECTION BOX WAS REPORTED AND THE CATHETER WAS NOT RECOGNIZED; REPLACING THE AUTO CONNECTION BOX RESOLVED THE CATHETER RECOGNITION ISSUE, AND TEST ABLATIONS WERE PROCEEDING. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24820910 ↗
• MalfunctionMay 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CATHETER 217F3 FREEZOR XTRA3 MED BLUE7F EXPERIENCED PHYSICAL DAMAGE. THE TIP OF THE ELECTROPHYSIOLOGY (EP) CATHETER WAS DAMAGED AND DETACHED FROM THE SHAFT. THE EP CATHETER WAS REPLACED. THE OUTCOME OF THE CASE IS UNKNOWN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22069459 ↗
• InjuryJan 18, 2024Adverse Event Without Identified Device or Use Problem; Protective Measures Problem; Adverse Event Without Identified Device or Use Problem; Protective Measures Problem

  IT WAS LATER REPORTED THAT THE 'ASYSTOLIC EVENT' WAS TRANSIENT HEART BLOCK THAT RETURNED AFTER CATHETER STIMULATION. THIS WAS CONFIRMED BY THE RECORDING SYSTEM SHOWED ATRIAL ELECTRICAL ACTIVITY BUT NO VENTRICULAR ACTIVITY. THE CATHETER PACING CARRIED OUT WAS CONFIRMED TO BE ELECTRICAL STIMULATION FROM A CORONARY SINUS CATHETER. THE PROCEDURE WAS ABORTED AFTER THE TRANSIENT HEART BLOCK OCCURRED AND DURING ACCESS VIA ARTERIAL GROIN TO THE AORTIC CUSP TO ASSESS LEFT SIDED PATHWAY.

  Patient problems: Asystole; Heart Block

  MAUDE report 18536696 ↗
• InjuryJan 18, 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, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE CATHETER MAY BE OUTSIDE THE PATIENT. THE ELECTROPHYSIOLOGY (EP) CATHETER WAS REPLACED TO RESOLVE THE SYSTEM  NOTICE. AFTER REPLACEMENT TEMPERATURES WERE NOT AS EXPECTED AND THE NEW ELECTROPHYSIOLOGY (EP) CATHETER DID NOT PASS THE SYSTEM FLUSH. THE ELECTROPHYSIOLOGY (EP) CATHETER WAS PULLED INTO THE SHEATH TO RESOLVE THE ISSUE. LATER, IT WAS NOTED THAT AN 'ASYSTOLIC EVENT' OCCURRED THAT WAS FURTHER DESCRIBED WITH A HEART BLOCK THAT WAS CAUSED BY NORMAL CATHETER MANIPULATION NEAR THE HIS BUNDLE VIA THE AORTA. ABLATION WAS DECIDED TO NOT BE PERFORMED DUE TO THE PATIENT'S REACTION AND LENGTH OF TIME THAT HAD BEEN ATTEMPTED TO FIND THE AREA OF INTEREST. CATHETER PACING WAS PERFORMED AND TITRATED. THE TRANSIENT HEART BLOCK RETURNED AFTER CATHETER STIMULATION. 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: Asystole; Heart Block

  MAUDE report 18536689 ↗
• InjuryJun 14, 2023Adverse 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 SAFETY SYSTEM DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION.  THE ELECTROPHYSIOLOGY (EP) CATHETER , ELECTRICAL UMBILICAL CABLE AND COAXIAL UMBILICAL CABLE WERE REPLACED THREE TIMES WITHOUT RESOLVING THE ISSUE. THE MAPPING CATHETER SYSTEM WAS ON, AND IT WAS TURNED OFF WHICH DID NOT RESOLVE THE ISSUE. THE RADIOFREQUENCY (RF) GENERATOR WAS ON THROUGHOUT THE PROCEDURE. THE CONSOLE WAS PLUGGED INTO ITS OWN OUTLET AND THE ISSUE REMAINED. THE CASE WAS ABORTED, AND THE PATIENT WAS NOT UNDER GENERAL ANESTHESIA. A PERICARDIAL EFFUSION WAS IDENTIFIED. PERICARDIOCENTESIS WAS PERFORMED. PATIENT HAS RECOVERED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pericardial Effusion

  MAUDE report 17128936 ↗
• MalfunctionMay 19, 2023Material Integrity Problem; Protective Measures Problem; Material Integrity Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE,SEVERAL SYSTEM NOTICES WERE RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED A HIGH LEVEL OF REFRIGERANT FLOW AND STOPPED THE INJECTION. THE ELECTROPHYSIOLOGY (EP) CATHETER, ELECTRICAL UMBILICAL CABLE AND CO AXIAL UMBILICAL CABLE WERE REPLACED WITHOUT RESOLVE. THE ELECTROPHYSIOLOGY (EP) CATHETER WAS REPLACED AGAIN FOR ANOTHER MODEL TO RESOLVE THE ISSUE. THE CASE WAS COMPLETED WITH CRYO. DATA FILES WERE REVIEWED AND PRESSURE MISMATCHES WERE NOTED WITH THE ELECTROPHYSIOLOGY (EP) CATHETER. A SERVICE WAS RECOMMENDED AND CARRIED OUT. NO ISSUES WERE NOTED AND THE CONSOLE WAS SERVICED AS APPROPRIATE NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16969575 ↗
• InjuryNov 17, 2022Adverse 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. IT WAS DIFFICULT TO ACCESS THE LOCATION OF THE ARRHYTHMIA USING THE FEMORAL ACCESS SITE. THEREFORE, THE INTERNAL JUGULAR (IJ) ACCESS SITE WAS USED TO FOR A BETTER TARGET AREA. THE PATIENT WAS A PEDIATRIC. IT WAS STATED THAT WARM TOWELS AND HEATING PADS WERE USE ON THE SHAFT OF THE ELECTROPHYSIOLOGY (EP) CATHETER. THE CASE WAS ABORTED. THE PATIENT WAS 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 15816823 ↗

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.