Covidien LLC recalls Covidien Emprint Standard Percutaneous Antenna with Thermosphere Technology, CA20L2 intended for use in percutaneous, l…

Recall date

November 15, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0627-2019

FDA classification

Class II

Brand / firm

Covidien LLC

Sold / distributed

US Nationwide

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.