Z-0558-2018 Class II Ongoing
FDA device recall Z-0558-2018 was initiated by Covidien LLC on August 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. Affected quantity: N/A.
Recall Details
- Product Type
- Devices
- Report Date
- February 14, 2018
- Initiation Date
- August 7, 2017
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm, Material CA20L1
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 10884521189546, Lot codes: S5LG003PX,S5MG016PX,S5MG018PX,S6AG004X,S6AG005X,S6AG007X,S6BG004X,S6BG011X,S6BG015PX,S6BG017X,S6CG002X,S6CG008X,S6CG014X,S6CG015X,S6CG016X,S6DG002X,S6DG005X,S6DG007X,S6DG010X,S6EG004X,S6EG006X,S6EG008X,S6FG005X,S6FG008X,S6GG007X,S6GG010X,S6HG001X,S6HG003PX,S6HG008PX,S6HG009PX,S6HG012X,S6JG001X,S6KG003X,S6KG005PRX,S6KG005PX,S6KG009X,S6KG016X,S6LG002X,S6MG003X,S6MG018X,S7AG003X,S7BG012PCX,S7CG004X,S7CG006X,S7CG008PCX,S7CG010PCX,S7CG017X,S7DG002X,S7DG005X,S7EG006X,S7FG010PX