ICEfx Cryoablation System - Refurbished FPRCH8000-02RRecalls & reported problems
Boston Scientific Corporation · Cryoablation System · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00859019006677), received between May 28, 2025 and May 28, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Insufficient Cooling” (2 reports).
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
Most reported problems
Device problems
- Insufficient Cooling2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 28, 2025Insufficient Cooling; Insufficient Cooling
IT WAS REPORTED INSUFFICIENT ICE OCCURRED. A ICEFX CRYOABLATION US SYSTEM WAS CHOSEN TO COMPLETE A CRYOABLATION PROCEDURE, INSUFFICIENT ICE OCCURRED DURING THE PROCEDURE. THE DETAILS OF HOW THE PROCEDURE WAS COMPETED WERE NOT PROVIDED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22096425 ↗MalfunctionMay 28, 2025Insufficient Cooling; Insufficient Cooling
IT WAS REPORTED INSUFFICIENT ICE OCCURRED. A ICEFX CRYOABLATION US SYSTEM WAS CHOSEN TO COMPLETE A CRYOABLATION PROCEDURE, INSUFFICIENT ICE OCCURRED DURING THE PROCEDURE. THE DETAILS OF HOW THE PROCEDURE WAS COMPETED WERE NOT PROVIDED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22096424 ↗
Other Unit, Cryosurgical, Accessories devices
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- 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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