Covidien LLC: Medical Device Recall in 2018 - (Recall #: Z-0559-2018)
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, 20cm (reinforced), Material CA20L2
Product Classification:
Class II
Date Initiated: August 7, 2017
Date Posted: February 14, 2018
Recall Number: Z-0559-2018
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 10884521706590, Lot codes: S6MG006PX,S6MG009PX,S6MG013PX,S6MG020PX,S7AG011X,S7AG012X,S7BG008X,S7CG003X,S7DG003X,S7DG009X,S7FG001X,S7FG002X,S7FG005X,S7FG008X
Distribution Pattern:
Nationwide including PR, Canada, China
Voluntary or Mandated:
Voluntary: Firm initiated