IceSphere® 1.5 Cryoablation Needle FPRPR3258Recalls & reported problems
Galil Medical Ltd · 1.5mm Cryoablation Needle · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290104830211), received between Nov 7, 2017 and Nov 7, 2017 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (2 reports).
1 FDA recall record name this device's identifier.
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
- Nov 18, 2020Class IICompleted
Complaint trend regarding needle shaft gas leaks.
Z-0674-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Device Operates Differently Than Expected2
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 7, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected
IT WAS REPORTED THAT AFTER THE FIRST CYCLE WAS COMPLETED, THE PHYSICIAN STARTED TO DO FREEZING FOR THE SECOND CYCLE. THEY USED TWO ICESPHERE NEEDLES AND ONE OF THEM STARTED TO BE THAWING EVEN THOUGH THE SYSTEM WAS IN FREEZE MODE. ALTHOUGH THE PROCEDURE WAS COMPLETED, THE TUMOR ABLATION WAS REPORTEDLY NOT SUCCESSFUL. THERE WERE NO KNOWN PATIENT CONSEQUENCES REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7008018 ↗MalfunctionNov 7, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected
IT WAS REPORTED THAT AFTER THE FIRST CYCLE WAS COMPLETED, THE PHYSICIAN STARTED TO DO FREEZING FOR THE SECOND CYCLE. THEY USED TWO ICESPHERE NEEDLES AND ONE OF THEM STARTED TO BE THAWING EVEN THOUGH THE SYSTEM WAS IN FREEZE MODE. ALTHOUGH THE PROCEDURE WAS COMPLETED, THE TUMOR ABLATION WAS REPORTEDLY NOT SUCCESSFUL. THERE WERE NO KNOWN PATIENT CONSEQUENCES REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7008015 ↗
Other Unit, Cryosurgical, Accessories devices
- IceFORCE® 2.1 CX 90° Cryoablation Needle FPRPR3602Boston Scientific Corporation · Unit, Cryosurgical, Accessories2 recalls4 deaths274 reports
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- IcePearl® 2.1 CX 90° Cryoablation Needle FPRPR3601Boston Scientific Corporation · Unit, Cryosurgical, Accessories2 recalls78 reports
- IceFORCE™ 2.1 CX L 90° Cryoablation Needle FPRPR3618Boston Scientific Corporation · Unit, Cryosurgical, Accessories2 recalls6 reports
- IceFORCE® 2.1 CX Cryoablation Needle FPRPR3604Boston Scientific Corporation · Unit, Cryosurgical, Accessories2 recalls3 reports
- 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 · 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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