Z-0560-2018 Class II Ongoing
FDA device recall Z-0560-2018 was initiated by Covidien LLC on Aug 7, 2017 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
- Feb 14, 2018
- Initiation Date
- Aug 7, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm, Material CA30L1
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
Nationwide including PR, Canada, China
Code Information
UDI 10884521189553, Lot codes: S5LG004PX,S6AG001X,S6BG002X,S6BG005X,S6BG016PX,S6CG003X,S6CG005X,S6CG017X,S6DG004X,S6EG001X,S6FG001X,S6FG006X,S6FG010X,S6KG002X,S6KG006PRX,S6KG006PX,S6LG004X,S6MG002X,S7CG001PCX,S7CG011PCX,S7CG015CX,S7EG001X,S7EG003X,S7FG011PX
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0560-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026