V2 ICE PROBE VP0600Recalls & reported problems
Sanarus Technologies, Inc. · The V2 ICE Probe is a single use, disposable probe designed for use with the Visica 2 Treatment System. The primary components of the V2 ICE Probe consists of a surgical stainless steel probe with an electrical warming component and an integrated T-Type thermocouple for internal temperature feedback. The V2 ICE Probe temperatures are internally and continuously monitored by the Visica 2 Console. · Class 2
Data updated Oct 16, 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 00868390000228), received between Jan 9, 2018 and Jan 9, 2018 — classified as 2 injuries.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).
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
Device problems
- Improper or Incorrect Procedure or Method1
- Temperature Problem1
Patient problems
- Injury1
- Superficial (First Degree) Burn1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 9, 2018Temperature Problem
DURING THE FIRST 30 SECONDS OF THE FIRST FREEZE THE PHYSCIAN NOTICED THE PROBE SHAFT WAS FREEZING UP TOWARDS THE HANDLE. HE IMMEDIATELY STOPPED THE PROCEDURE AND REMOVED THE PROBE. ANOTHER PROBE WAS USED TO COMPLETE THE PROCEDURE. INITIAL REPORT FROM THE SITE STATED THERE WAS NO INJURY TO THE PATIENT. DURING A FOLLOW UP VISIT IT WAS STATED THAT THE PATIENT SUFFERED A FIRST DEGREE BURN.
Patient problems: Superficial (First Degree) Burn
MAUDE report 7176878 ↗InjuryJan 9, 2018Improper or Incorrect Procedure or Method
THE PHYSICIAN REPORTED THAT THE PATIENT HAD MINOR FROSTBITE AT THE INCISION SITE. THE SYSTEM WAS TURNED ON PREMATURELY CAUSING THE ICE TO FORM BEFORE THE PROBE WAS COMPLETELY POSITIONED. AT THE TIME, THE PATIENT DID NOT HAVE ANYTHING VISIBLY WRONG WITH HER. IT WAS LATE DISCOVERED AT A FOLLOW UP APPOINTMENT THAT THE PATIENT DID INDEED HAVE FROSTBITE AT THE SITE OF THE INCISION; BUT IT HAS BEEN TAKEN CARE OF AND THERE ARE NO LONG TERM SIDE EFFECTS TO REPORT ACCORDING THE PHYSICIAN.
Patient problems: Injury
MAUDE report 7176877 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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