Covidien LLC: Medical Device Recall in 2018 - (Recall #: Z-0557-2018)

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, 15cm (reinforced), Material CA15L2

Product Classification:

Class II

Date Initiated: August 7, 2017

Date Posted: February 14, 2018

Recall Number: Z-0557-2018

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 10884521706583, Lot codes: S6MG005PX,S6MG008PX,S6MG012PX,S6MG019PX,S7AG001PX,S7AG006X,S7AG010X,S7AG013X,S7BG001X,S7BG003X,S7BG007X,S7BG013X,S7CG002X,S7CG005X,S7CG007X,S7CG013X,S7EG009X,S7FG003X,S7FG004X,S7FG007X

Distribution Pattern:

Nationwide including PR, Canada, China

Voluntary or Mandated:

Voluntary: Firm initiated