PROSENSE™ SYSTEM 100-127 VAC FAS3000000Recalls & reported problems
Icecure Medical Ltd · Class 2
All models of PROSENSE SYSTEM 100-127 VAC (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07290015487160), received between May 11, 2025 and May 17, 2026 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Sep 16, 2019Class IIOpen, Classified
Updated User Manual DSR3200000 Rev. E to include the safety guidelines in case of any mechanical damage (e.g. bent cryoprobe)
Z-2650-2023 · Root cause: Other · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Detachment of Device or Device Component1
- Insufficient Device Problem Information1
Patient problems
- Cancer1
- No Clinical Signs, Symptoms or Conditions1
- Pneumothorax1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 17, 2026Adverse Event Without Identified Device or Use Problem
PATIENT UNDERWENT LUNG CRYOABLATION PROCEDURE. DURING THE SECOND PROBE INSERTION/POSITIONING, A MILD PNEUMOTHORAX OCCURRED INTRA-PROCEDURALLY. THE PHYSICIAN ASSESSED THE EVENT AS A NON-SERIOUS, MILD ADVERSE EVENT WITH NO EVIDENCE OF DEVICE MALFUNCTION OR DEFICIENCY. THE EVENT ALIGNS WITH KNOWN RISKS OF LUNG CRYOABLATION PROCEDURES DESCRIBED IN THE DEVICE LABELING AND USER MANUAL, AND THE COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS.
Patient problems: Pneumothorax
MAUDE report 25196270 ↗InjuryDec 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
MalfunctionMay 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
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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 · each recall links to the FDA recall notice
- 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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