PROSENSE™ SYSTEM 100-127 VAC FAS3000000-2Recalls & reported problems
Icecure Medical Ltd · PROSENSE™ SYSTEM 100-127 VAC Straight cryohandle · 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
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
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.
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 ↗
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- IcePearl™ 2.1 CX L 90° Cryoablation Needle FPRPR3617Boston Scientific Corporation · Unit, Cryosurgical, Accessories2 recalls1 report
- IceRod® He-Thaw Prostate Cryoablation Kit / Presice® System FPRPR4570Galil Medical Ltd · Unit, Cryosurgical, Accessories2 recalls0 reports
- IceRod® i-Thaw® Prostate Cryoablation Kit / Presice® System FPRPR4070Galil Medical Ltd · Unit, Cryosurgical, Accessories2 recalls0 reports
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
- 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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