IceSeed® 1.5 Cryoablation Needle FPRPR3201Recalls & 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 07290104830181), received between Jun 29, 2018 and Jun 29, 2018 — 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-0676-2021 · 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
- Patient Problem/Medical Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS COMPLAINT IS DERIVED FROM A LITERATURE ARTICLE PUBLICIZED IN 2016 IN UROLOGY TITLED "SALVAGE CRYOTHERAPY WITH THIRD-GENERATION TECHNOLOGY FOR LOCALLY RECURRENT PROSTATE CANCER AFTER RADIATION THERAPY". FROM JANUARY 2006 TO JULY 2010, 32 PATIENTS UNDERWENT SALVAGE CRYOABLATION FOR LOCALIZED RECURRENT PROSTATE CANCER AFTER RADIATION THERAPY (4 PATIENTS HAD EXTERNAL BEAM THERAPY, AND 28 PATIENTS HAD BRACHYTHERAPY). PATIENTS ELIGIBLE FOR CRYOTHERAPY HAD COMPLETED RADIATION THERAPY AT LEAST 18 MONTHS BEFORE EVALUATION. ALL PATIENTS HAD LOCAL AND BIOPSY-PROVEN RECURRENCE AND HAD NEGATIVE METASTATIC SCREENING WITH ABDOMINAL AND PELVIC MAGNETIC RESONANCE IMAGING (MRI) AND WHOLE-BODY BONE SCAN. ALL PATIENTS HAD RECEIVED 3 MONTHS OF COMBINED ANDROGEN DEPRIVATION THERAPY BEFORE CRYOTHERAPY AND DID NOT CONTINUE WITH ADJUVANT ANDROGEN DEPRIVATION AFTER CRYOTHERAPY. ALL CRYOABLATION PROCEDURES WERE PERFORMED IN-HOSPITAL USING THE CRYO-HIT SYSTEM AND ICESEED CRYONEEDLES. IN MOST CASES, 5-7 CRYONEEDLES WERE INSERTED. MORE ATTENTION WAS PAID NOT TO PLACE CRYONEEDLES TOO CLOSE TO THE POSTERIOR PROSTATE CAPSULE, THE CLOSEST RELATIONSHIP WITH THE RECTAL WALL. FREEZING WAS STOPPED WHEN THE ICEBALL
Patient problems: Patient Problem/Medical Problem
MAUDE report 7653511 ↗
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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