PROSENSE SYSTEM 100-127 VACRecalls & reported problems across all models
Icecure Medical Ltd · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one PROSENSE SYSTEM 100-127 VAC model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 1
We found 2 models of PROSENSE SYSTEM 100-127 VAC by Icecure Medical Ltd in the FDA's device registry (GUDID). Together they are named in 3 adverse event reports in the FDA's MAUDE database, 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 at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
PROSENSE SYSTEM 100-127 VAC recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Sep 16, 2019Open, 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 · names 2 of these models · Recall details · FDA record ↗
Most reported PROSENSE SYSTEM 100-127 VAC 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
PROSENSE SYSTEM 100-127 VAC models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PROSENSE™ SYSTEM 100-127 VAC FAS3000000Unit, Cryosurgical, Accessories1 recall3 reports
- PROSENSE™ SYSTEM 100-127 VAC FAS3000000-2Unit, Cryosurgical, Accessories1 recall0 reports
Recent PROSENSE SYSTEM 100-127 VAC adverse event reports
The 3 most recent reports across all models, 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
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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