Covidien LLC: Medical Device Recall in 2018 - (Recall #: Z-0560-2018)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2018.
Data Source: FDA.
Product Description:
Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm, Material CA30L1
Product Classification:
Class II
Date Initiated: August 7, 2017
Date Posted: February 14, 2018
Recall Number: Z-0560-2018
Event ID: 79075
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.
Status: Ongoing
Product Quantity: N/A
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
Distribution Pattern:
Nationwide including PR, Canada, China
Voluntary or Mandated:
Voluntary: Firm initiated