Cryoprobe D3.4 mm/10G, 140 mm, Trocar, Elliptic. FAP7200000Recalls & reported problems
Icecure Medical Ltd · Cryoprobe-Use only with IceCure Cryogenic Device · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290015487030), received between Sep 3, 2024 and Jan 19, 2025 — classified as 1 injury, 1 malfunction.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Improper or Incorrect Procedure or Method1
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.
MalfunctionJan 19, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
CRYOPROBE DISCONNECTED BY THE USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21187706 ↗InjurySep 3, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
TIP DISCONNECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20128527 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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