IcePearl™ 2.1 CX L 90° Cryoablation Needle FPRPR3617Recalls & reported problems
Boston Scientific Corporation · 2.1 mm 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
- 2
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290104831072), received between Jul 21, 2026 and Jul 21, 2026 — classified as 1 injury.
2 FDA recall records 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.
Reports received per month
Recalls naming this device
- Nov 18, 2020Class IICompleted
Complaint trend regarding needle shaft gas leaks.
Z-0662-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jun 4, 2020Class IITerminated
The needle surface deteriorated due to unexpected electrolysis during procedure.
Z-2682-2020 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Cellulitis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 21, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT CELLULITIS OCCURRED, REQUIRING INTERVENTION. THE PURPOSE OF THIS ARTICLE WAS TO DESCRIBE A NOVEL CASE SERIES USING RECTAL SPACER GEL TO DISPLACE AND PROTECT THE RECTUM DURING PROSTATE CANCER CRYOABLATION. FIFTY MEN WITH CLINICALLY LOCALIZED GRADE GROUP 1-5 PROSTATE CANCER UNDERWENT CONCURRENT RECTAL SPACER GEL AND PRIMARY (N=27) OR SALVAGE (N=23) PROSTATE CRYOABLATION USING THE SPACEOAR HYDROGEL AND ICEPEARL (2.1 MM/14 GAUGE) AND/OR ICESEED (1.5 MM/17 GAUGE) CRYOABLATION NEEDLE(S). OF THE 50 CASES, THERE WAS ONLY ONE CASE WITH A COMPLICATION OF PERINEAL CELLULITIS, AS A CLAVIEN-DINDO GRADE II COMPLICATION. THE CELLULITIS WAS ABLE TO BE RESOLVED WITH AN INCISION AND DRAINAGE OF THE FLUID COLLECTION AND ANTIBIOTICS. THERE WERE NO FURTHER COMPLICATIONS OBSERVED.
Patient problems: Cellulitis
MAUDE report 25896682 ↗
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
- 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
- Three IcePearl® 2.1 CX Prostate Cryoablation KitVisual-ICE® System FPRPR3608Boston Scientific Corporation · 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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