Z-0627-2019 Class II Ongoing
FDA device recall Z-0627-2019 was initiated by Covidien LLC on Nov 15, 2018 and is designated Class II. 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. The recall status is ongoing.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 26, 2018
- Initiation Date
- Nov 15, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
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.
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.
Distribution Pattern
US Nationwide
Code Information
GTIN Number - 10884521706590 Lot Numbers- S7HG001PX S7HG004KX S7HG010KX S7HG011KX S7HG012KX S7HG030LX S7HG031LX S7HG035LX S7HG039LX S7HG042LX S7HG043X S7JG006X S7JG010X S7JG013X S7JG014X S7KG008LX S7KG009LX S7KG010LX S7KG041X S7KG043X S7LG003X S7LG004X S7MG003X S7MG004LX S7MG017PX S7MG029X S8BG001X S8BG002X S8BG006X S8CG001X S8CG008LX S8CG009X S8CG018X S8CG023X S8DG019LX S8DG020LX S8DG021LX S8DG022LX S8DG023X S8DG025X
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0627-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026