Recall Z-0556-2018— Covidien LLC

Name: FDA recall Z-0556-2018
Creator: U.S. Food and Drug Administration
Published: 2017-08-07

Class II · Ongoing

Class II FDA medical device recall by Covidien LLC, initiated 2017-08-07. It names one FDA 510(k) clearance: K133821. Product: Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm, Material CA15L1. Reason: 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..

Recalling firm: Covidien LLC
Classification: Class II
Status: Ongoing
Initiated: 2017-08-07
Firm location: North Haven, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K133821 — EMPRINT ABLATION SYSTEMCovidien, LLC·cleared 2014-04-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm, Material CA15L1

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.