Covidien LLC recalls Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm (reinforced), Material CA15L2

Recall date

August 7, 2017

Source

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

Recall number

Z-0557-2018

FDA classification

Class II

Brand / firm

Covidien LLC

Sold / distributed

Nationwide including PR, Canada, China

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 Percutaneous Antenna with Thermosphere Technology, 15cm (reinforced), Material CA15L2