Covidien LLC: Medical Device Recall in 2018 - (Recall #: Z-0561-2018)

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 (reinforced), Material CA30L2

Product Classification:

Class II

Date Initiated: August 7, 2017

Date Posted: February 14, 2018

Recall Number: Z-0561-2018

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 10884521706606, Lot codes: S6MG007PX,S6MG010PX,S6MG016PX,S7AG002PX,S7BG005X,S7BG009X,S7DG004X,S7FG006X

Distribution Pattern:

Nationwide including PR, Canada, China

Voluntary or Mandated:

Voluntary: Firm initiated