Galil Medical Urethral Warming Set FPRPR4003Recalls & reported problems
Boston Scientific Corporation · Set of disposable components used in conjunction with a warmer system and peristaltic pump, is intended to warm urethral tissue when performing cryoablative destruction of prostatic tissue with a Galil Medical Cryoablation System · 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
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290104830518), received between Sep 19, 2022 and Sep 19, 2022 — classified as 1 injury.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Dysuria1
- Urinary Retention1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PROCRY INVESTIGATOR-INITIATED CLINICAL TRIAL (PROSTATE CANCER FOCI TARGETED CRYOTHERAPY PROCRY). IT WAS REPORTED THAT HOSPITALIZATION WAS EXTENDED. A URETHRAL WARMING SET WAS SELECTED FOR USE IN A CRYOABLATION PROCEDURE. THERE WAS NO PROBLEM WITH THE DEVICE, AND THE PROCEDURE WAS COMPLETED. THE NEXT DAY, THE BALLOON CATHETER WAS REMOVED FROM THE URETHRA AND STARTED TO URINATE, BUT RESIDUAL URINE WAS OBSERVED. THEREFORE, THE PATIENT'S DISCHARGE FROM THE HOSPITAL WAS EXTENDED FOR OBSERVATION OF URINARY DRAINAGE DUE TO POSTOPERATIVE DYSURIA. IT WAS ALSO SUSPECTED DYSURIA DUE TO THE SIDE EFFECT OF THE CONCOMITANT DRUG SOLIFENACIN SUCCINATE OD TABLETS 5 MG (COMPLICATION: OVERACTIVE BLADDER), AND DISCONTINUED THE DRUG ON THE 9TH. ON THE FOLLOWING TWO DAYS, ALTHOUGH RESIDUAL URINE PERSISTED, DYSURIA AND THE PATIENT'S SYMPTOMS IMPROVED, AND IT WAS JUDGED THAT THE PATIENT COULD BE DISCHARGED FROM THE HOSPITAL, AND THE PATIENT WAS DISCHARGED.
Patient problems: Dysuria; Urinary Retention
MAUDE report 15445274 ↗
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
- 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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