Freezor™ Xtra 217F5Recalls & reported problems
Medtronic, Inc. · CATHETER 217F5 FREEZOR XTRA5 LG 7F · Class 3
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000542115), received between Mar 11, 2024 and Mar 11, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Temperature 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Temperature Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 11, 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, THE ELECTROPHYSIOLOGY (EP) CATHETER COULD NOT GET WARM AND INITIATE THE SYSTEM CHECK. THE ELECTROPHYSIOLOGY (EP) CATHETER WAS REPLACED WITHOUT RESOLUTION. THE ELECTROPHYSIOLOGY (EP) CATHETER WAS REPLACED AGAIN WITH ANOTHER MANUFACTURER'S PRODUCT. THE CASE WAS SWITCHED TO RADIOFREQUENCY (RF) BUT WAS LATER ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18875759 ↗InjuryMar 11, 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, THE ELECTROPHYSIOLOGY (EP) CATHETER COULD NOT GET WARM AND INITIATE THE SYSTEM CHECK. THE ELECTROPHYSIOLOGY (EP) CATHETER WAS REPLACED WITHOUT RESOLUTION. THE ELECTROPHYSIOLOGY (EP) CATHETER WAS REPLACED AGAIN WITH ANOTHER MANUFACTURER'S PRODUCT. THE CASE WAS SWITCHED TO RADIOFREQUENCY (RF) BUT WAS LATER ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18875731 ↗
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 · TerminatedMedtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing cardiac ablation procedures.
- Z-1452-06 · Aug 4, 2006 · Terminated7F Freezor Cardiac Cryoablation catheter, REF # 207F1. CryoCath Technologies Inc.
Other Cardiac ablation percutaneous catheter devices
- THERMOCOOL SMARTTOUCH SF D134805Biosense Webster Inc · Cardiac ablation percutaneous catheter1 recall176 deaths4,106 reports
- THERMOCOOL SMARTTOUCH SF D134804Biosense Webster Inc · Cardiac ablation percutaneous catheter44 deaths784 reports
- THERMOCOOL SMARTTOUCH SF D134801Biosense Webster Inc · Cardiac ablation percutaneous catheter15 deaths608 reports
- ThermoCool SmartTouch D132705Biosense Webster Inc · Cardiac ablation percutaneous catheter25 deaths574 reports
- THERMOCOOL SMARTTOUCH SF D134702Biosense Webster Inc · Cardiac ablation percutaneous catheter19 deaths366 reports
- THERMOCOOL SMARTTOUCH SF D134701Biosense Webster Inc · Cardiac ablation percutaneous catheter11 deaths278 reports
- ThermoCool SmartTouch D133602Biosense Webster Inc · Cardiac ablation percutaneous catheter8 deaths225 reports
- SMARTABLATE SAT001Biosense Webster Inc · Cardiac ablation percutaneous catheter185 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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