Visual-ICE MRI Cryoablation Console FPRCH7000Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00859019006318), received between May 21, 2022 and Aug 7, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Insufficient Cooling” (3 reports).

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.

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.

• MalfunctionAug 7, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT A MASSIVE ICEBALL WAS CREATED FASTER THAN EXPECTED AND THE PROCEDURE HAD TO BE CANCELLED. THIS VI MRI CRYOABLATION CONSOLE WAS SELECTED FOR MRI CRYOABLATION OF A DESMOID TUMOR. DURING THE PROCEDURE, ALL SIXTEEN NEEDLES WERE TESTED AND PASSED; HOWEVER, THE STICK FUNCTION ON THE CONSOLE WAS NOT WORKING. THEY PHYSICIAN OPTED TO TURNED THE 10% FREEZE OPTION ON TO GET A SIMILAR STICK EFFECT, BUT UPON SCANNING THE PATIENT THEY OBSERVED A MASSIVE SIZE ICE BALL (8CM IN 10 MINUTES). THIS IS NOT NORMAL AND APPEARS THE MACHINE WAS NOT PRODUCING THE CORRECT ICE AMOUNT. THE THAW FUNCTION WAS QUICKLY TURNED ON TO PREVENT ICE FROM GROWING MORE AND THE PROCEDURE WAS CANCELLED (POST-SEDATION). THE PATIENT WAS MONITORED CLOSE AND THERE HAVE BEEN NO PATIENT COMPLICATIONS OR ADDITIONAL TREATMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19933415 ↗
• MalfunctionNov 29, 2022Insufficient Cooling; Gas/Air Leak; Insufficient Cooling; Gas/Air Leak

  IT WAS REPORTED THAT THIS UNIT WAS GENERATING SUBOPTIMAL ICE. A VI MRI CRYOABLATION CONSOLE WAS USED IN A CRYOABLATION PROCEDURE. THE CONSOLE DID NOT GENERATE SUFFICIENT ICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15880504 ↗
• MalfunctionJun 22, 2022Insufficient Cooling; Insufficient Cooling

  IT WAS REPORTED THAT INSUFFICIENT ICE OCCURRED. A CRYO CONSOLE AND AN ICEROD 90 DEGREE MRI NEEDLE WERE SELECTED FOR TREATMENT OF A KIDNEY INJURY OF 25X21. DURING THE FIRST FREEZE AT 10 MINUTES, AN ICEBALL OF 44X17 WAS NOTICED. THE PHYSICIAN EXPECTED TO SEE AN ICEBALL OF 45X26. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. DURING THE MAGNETIC RESONANCE IMAGING (MRI) EXAM, FOUR MONTHS AFTER THE PROCEDURE, THE ICEBALL SIZE WAS DEEMED NOT SUFFICIENT IN COVERING THE TARGETED TISSUE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14780721 ↗
• MalfunctionMay 21, 2022Insufficient Cooling; Insufficient Cooling

  IT WAS REPORTED THAT THERE WAS INSUFFICIENT ICE. A VISUAL ICE MRI CRYOABLATION CONSOLE WAS SELECTED FOR A CRYOABLATION PROCEDURE. IT WAS REPORTED THAT THERE WERE ISSUES WITH GETTING THE RIGHT SIZE ICEBALLS. THE DEVICE SEEMED TO BE WORKING AT 50% CAPACITY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14466260 ↗