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

Recall Z-0627-2019 — Covidien Emprint Standard Percutaneous Antenna with Thermosphere Technology, CA20L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of nonresectable liver tumors.

U.S. FDA — Device Enforcement · United States · 2018-11-15 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0627-2019
Date of alert
2018-11-15
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Covidien LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10884521706590
Reported risk: The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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