IceEDGE® 2.4 90° Cryoablation Needle FPRPR3506Recalls & reported problems
Galil Medical Ltd · 2.4mm 90 degree Cryoablation Needle · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07290104830594), received between Jun 13, 2017 and Jan 11, 2018 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (4 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-0677-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Device Operates Differently Than Expected4
- Failure to Fire2
Patient problems
- No Consequences Or Impact To Patient3
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 11, 2018Failure to Fire; Device Operates Differently Than Expected; Failure to Fire; Device Operates Differently Than Expected
PRIOR TO A RENAL CRYOABLATION PROCEDURE, 2 ICEEDGE 90 DEGREE NEEDLES AND SYSTEM TESTED FINE WITH NO ISSUES TO REPORT. DURING THE FIRST FREEZE CYCLE ONE NEEDLE DID NOT CREATE ICE AS EXPECTED. THE ICEBALL WAS REPORTEDLY SMALL. THE NEEDLE WAS RE-POSITIONED AND THE SAME ISSUE OCCURRED DURING THE SECOND AND THIRD FREEZE CYCLE. THE PROCEDURE WAS COMPLETED WITH BOTH NEEDLES AS EXPECTED WITH NO INJURY TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7184365 ↗MalfunctionNov 7, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected
IT WAS REPORTED THAT DURING THE TREATMENT, THE DOCTOR NOTICED THE SHAFTS OF TWO OF THE ICESPHERE 1.5 90 CRYOABLATION NEEDLES STARTED TO COLLECT FROST. THE PATIENT'S SKIN WAS PROTECTED TO PREVENT ANY INJURY. THE PROCEDURE WAS COMPLETED AS EXPECTED WITH NO INJURY TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7008010 ↗MalfunctionNov 7, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected
IT WAS REPORTED THAT DURING THE TREATMENT, THE DOCTOR NOTICED THE SHAFTS OF TWO OF THE ICESPHERE 1.5 90 CRYOABLATION NEEDLES STARTED TO COLLECT FROST. THE PATIENT'S SKIN WAS PROTECTED TO PREVENT ANY INJURY. THE PROCEDURE WAS COMPLETED AS EXPECTED WITH NO INJURY TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7008007 ↗MalfunctionJun 13, 2017Failure to Fire; Device Operates Differently Than Expected; Failure to Fire; Device Operates Differently Than Expected
PRIOR TO A CRYOABLATION PROCEDURE, ONE ICEEDGE AND TWO ICEROD NEEDLES TESTED FINE WITH NO ISSUES. HOWEVER, DURING THE 1ST FREEZE CYCLE THE ICEBALL ON THE EDGE NEEDLE WAS VERY SMALL. THE PHYSICIAN CONTINUED TO USE ALL NEEDLES TO COMPLETE THE PROCEDURE, BUT DOCTOR WAS NOT HAPPY WITH THE PERFORMANCE OF THE ICEEDGE. THERE WAS NO INJURY TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6637765 ↗
Other Unit, Cryosurgical, Accessories devices
- IceFORCE® 2.1 CX 90° Cryoablation Needle FPRPR3602Boston Scientific Corporation · Unit, Cryosurgical, Accessories2 recalls4 deaths274 reports
- IceRod® 1.5 CX 90° Cryoablation Needle FPRPR3533Boston Scientific Corporation · Unit, Cryosurgical, Accessories1 recall168 reports
- 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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