Visual-ICE® Cryoablation System FPRCH6000-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00859019006462), received between Dec 2, 2022 and May 27, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Insufficient Cooling” (4 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 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.

• MalfunctionMay 27, 2025Insufficient Cooling; Insufficient Cooling

  IT WAS REPORTED INSUFFICIENT ICE OCCURRED. A VISUAL-ICE CRYOABLATION SYSTEM WAS CHOSEN TO COMPLETE A RENAL TUMOR CRYOABLATION. THE PHYSICIAN AND ANOTHER PHYSICIAN NOTED THE ICE FORMATION WAS LESS THAN EXPECTED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PHYSICIAN BELIEVED THE TREATMENT WAS ADEQUATE EVEN THOUGH THE ICE FORMATION WAS LESS THAN EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22090573 ↗
• MalfunctionMar 24, 2025Insufficient Cooling; Display or Visual Feedback Problem; Temperature Problem; Insufficient Cooling; Display or Visual Feedback Problem; Temperature Problem

  IT WAS REPORTED THAT INSUFFICIENT ICE OCCURRED. A VISUAL-ICE CRYOABLATION SYSTEM WAS SELECTED FOR A CRYOABLATION PROCEDURE. DURING THE SECOND FREEZE OF THE PROCEDURE, THE CONSOLE DID NOT FREEZE AS EXPECTED AND INSUFFICIENT ICE OCCURRED. IT WAS NOTED THAT THIS ISSUE HAS OCCURRED WITH THE SAME SYSTEM ON MORE THAN ONE OCCASION. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21679785 ↗
• MalfunctionMar 13, 2025Insufficient Cooling; Temperature Problem; Insufficient Cooling; Temperature Problem

  IT WAS REPORTED THAT INSUFFICIENT ICE OCCURRED. A VISUAL-ICE CRYOABLATION SYSTEM WAS SELECTED FOR A CRYOABLATION PROCEDURE TO TREAT A RENAL TUMOR. DURING THE SECOND FREEZE, HOWEVER, THE CONSOLE DID NOT FREEZE PROPERLY. THE CASE WAS NOT ABLE TO BE COMPLETED, AND THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21595800 ↗
• MalfunctionDec 2, 2022Insufficient Cooling; Insufficient Cooling

  IT WAS REPORTED THAT THE SYSTEM WAS PRODUCING INSUFFICIENT ICE. THE VISUAL-ICE CRYOABLATION SYSTEM WAS SELECTED FOR A CRYOABLATION PROCEDURE TO TREAT A RENAL TUMOR. DURING TESTING, HOWEVER, THE SYSTEM WAS PRODUCING INSUFFICIENT ICE. THE FIRST PROBE WAS TESTED, AND NO ICE BALL WAS FORMED IN THE SALINE. A SECOND PROBE OF THE SAME LOT NUMBER WAS INSERTED INTO A DIFFERENT CHANNEL AND TESTED, AND THE SAME ISSUE OF NO ICE BALL FORMATION OCCURRED. A THIRD PROBE FROM A DIFFERENT LOT WAS TESTED AND THE SAME ISSUE OF NO ICE BALL FORMATION OCCURRED. THE SYSTEM WAS SHUT DOWN, THE ARGON GAS TANKS WERE DISCONNECTED AND RECONNECTED, AND THE SEAL ON THE TANKS AND THE MACHINE WERE CHECKED AGAIN. THE SYSTEM WAS TURNED BACK ON AND THE SECOND AND THIRD PROBES WERE RECONNECTED. WHEN INSERTING THE PROBES, THERE WAS RESISTANCE, BUT THEY WERE ABLE TO BE INSERTED AND TESTED AGAIN. HOWEVER, NO ICE BALL HAD FORMED AGAIN. THE RADIOLOGIST NOTED THAT THE PROBES FELT HOT DURING THE LAST TEST. THE CRYOABLATION SYSTEM WAS NOT USED FOR THE PROCEDURE, AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE METHOD. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE DEFECTIVE NEEDLES WERE TESTED AGAIN WITH THE SAME VISUAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15905690 ↗