IceRod® 1.5 90° Cryoablation Needle FPRPR3204Recalls & reported problems
Galil Medical Ltd · 1.5mm 90 degree Cryoablation Needle · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290104830242), received between Oct 21, 2019 and Oct 21, 2019 — classified as 1 injury.
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-0668-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Peroneal Nerve Palsy1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS REPORT IS DERIVED FROM A LITERATURE ARTICLE PUBLICIZED IN CIRSE 2019 TITLED "LOCAL CONTROL AND ANALGESIC EFFICACY OF PERCUTANEOUS CRYOABLATION FOR DESMOID TUMORS." PERCUTANEOUS CRYOABLATION USING CT OR ULTRASOUND WAS PERFORMED ON 41 DESMOID TUMORS IN 34 PATIENTS BETWEEN JULY 2012 AND SEPTEMBER 2016 USING GALIL MEDICAL'S VISUAL-ICE SYSTEM AND VARIOUS GALIL CRYOPROBES. PATIENTS RECEIVED CLINICAL AND RADIOLOGICAL FOLLOW-UP AT 6 MONTHS POST-PROCEDURE, WITH PAIN-RATING AND ADVERSE EVENTS BEING RECORDED. THE ARTICLE REPORTED THAT TWO PATIENTS HAD CIRSE CLASS GRADE 4 COMPLICATIONS INVOLVING PALSY OF THE COMMON FIBULAR NERVE. PATIENTS WITH GRADE 4 COMPLICATIONS ARE AS FOLLOWS: PATIENT 2 WAS A (B)(6) YEAR OLD FEMALE WHO HAD CRYOABLATION IN THE RIGHT LEG USING 3 ICEROD PROBES. PATIENT 3 WAS A (B)(6) YEAR OLD MALE WHO HAD CRYOABLATION IN THE RIGHT LEG USING 3 ICEROD PROBES. FOLLOW UP WITH THE CORRESPONDING AUTHOR WAS PERFORMED WHERE MORE INFORMATION WAS PROVIDED REGARDING PATIENT 3: PATIENT "WAS TREATED BY CRYOABLATION OF A DESMOID TUMOR WITH CT GUIDANCE (POPLITEAL FOSSA) BY ANOTHER IR. THE PATIENT HAD A PALSY OF THE FIBULAR NERVE WITH COMPLETE MOTOR AND SENSORY DEFECT. THE PATIENT HAD H
Patient problems: Peroneal Nerve Palsy
MAUDE report 9214001 ↗
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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