Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2678-2020 — Ablation Galil Technology, IceFORCE 2.1 CX Prostate Kit Visual ICE System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.

U.S. FDA — Device Enforcement · United States · 2020-06-04 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2678-2020
Date of alert
2020-06-04
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Boston Scientific Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
7290104831034
Reported risk: The needle surface deteriorated due to unexpected electrolysis during procedure.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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