Covidien LLC: Medical Device Recall in 2018 - (Recall #: Z-0625-2019)

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 Long Percutaneous Antenna with Thermosphere Technology, Material CA30L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of nonresectable liver tumors.

Product Classification:

Class II

Date Initiated: November 15, 2018

Date Posted: December 26, 2018

Recall Number: Z-0625-2019

Event ID: 81595

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:

Code Information:

GTIN Number - 10884521706606 Lot Numbers- S7HG007KX S7HG008KX S7HG009KX S7HG032LX S7HG033LX S7HG034LX S7JG008LX S7JG009X S7JG012X S7KG012LX S7KG038QX S7LG009X S7MG010LX S7MG019X S8BG004X S8BG005X S8CG002X S8DG001X S8DG026X S8EG004X

Distribution Pattern:

US Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated