Covidien Llc: Medical Device Recall in 2021 - (Recall #: Z-0210-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1

Product Classification:

Class II

Date Initiated: September 29, 2021

Date Posted: November 17, 2021

Recall Number: Z-0210-2022

Event ID: 88817

Reason for Recall:

The firm identified an error in the device temperature monitoring circuitry which is designed to interrupt energy delivery in the event of a primary cooling system failure. Use of an affected device in conjunction with a primary cooling system failure could lead to the applicator tip overheating and associated heat damage which could result in an allergic/toxic reaction, unintended tissue ablation, tissue burn, and/or a delay of treatment while an alternate device is located.

Status: Terminated

Product Quantity: 14 units

Code Information:

Lot 516840

Distribution Pattern:

No domestic distribution. Foreign distribution to Hong Kong and UK.

Voluntary or Mandated:

Voluntary: Firm initiated