IceSeed® 1.5 MRI Cryoablation Needle FPRPR3192Recalls & reported problems
Boston Scientific Corporation · 1.5mm 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 07290104830266), received between Oct 17, 2019 and Oct 17, 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-0681-2021 · 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
- Post Operative Wound Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT QUADRANT PROSTATE MRI CRYOABLATION WITH 6 ICESEED NEEDLES PLACED THROUGH THE PROSTATE GRID, 5 MM APART ON (B)(6) 2019. WARM SALINE SHOWER WAS APPLIED TO PERINEUM DURING THE PROCEDURE. THE PHYSICIAN NOTED 3 FREEZE/THAW CYCLES, WITH LAST FREEZE FOLLOWING WITHDRAWAL OF ONE NEEDLE TO TREAT THE APICAL REGION OF THE PROSTATE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO EVIDENCE OF THERMAL SKIN INJURY AT THE END OF THE PROCEDURE. IN RETROSPECT, THE PHYSICIAN NOTES POTENTIAL CHANGES AROUND THE NEEDLE SHAFTS ON MRI, BUT AT THE TIME CHALLENGING TO SEE DUE TO ARTIFACT. THE PATIENT PRESENTED 7-10 DAYS AFTER PROCEDURE WITH PERINEAL WOUND AND INFECTION. MRI SHOWED ABLATION OF THE INTENDED PROSTATE REGION AS WELL AS A CONE SHAPED AREA OF NECROSIS IN THE PERIPHERAL FAT EXTENDING FROM THE BASE OF THE PENIS UP TO AND INCLUDING THE SKIN. THE PATIENT WAS ADMITTED, SURGERY CONSULTED, AND IV ANTIBIOTICS STARTED. SURGERY FOR WOUND DEBRIDEMENT FOLLOWED BY WOUND PACK AND OUTPATIENT WOUND CARE. NO DEVICE MALFUNCTION WAS REPORTED IN ASSOCIATION WITH THIS EVENT. THE NEEDLES WILL NOT BE RETURNED FOR INVESTIGATION.
Patient problems: Post Operative Wound Infection
MAUDE report 9205398 ↗
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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