Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Short Percutaneous Antenna with Thermosphere" Technology Standard Percutaneous Antenna with Recalled by Covidien Medical Products (Shanghai) Manufacturing L.L.C. Due to Medtronic is voluntarily recalling specific item codes and...

Date: February 23, 2016
Company: Covidien Medical Products (Shanghai) Manufacturing L.L.C.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Covidien Medical Products (Shanghai) Manufacturing L.L.C. directly.

Affected Products

Short Percutaneous Antenna with Thermosphere" Technology Standard Percutaneous Antenna with Thermosphere" Technology; The product is packaged in a blister with a tyvek lid, contained in a display box. The numbers of units per carton is 1. Long Percutaneous Antenna with Thermosphere" Technology Product Usage: The Covidien Emprint Ablation System is intended for use in percutaneous,laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of non-resectable liver tumors. The CovidienEmprint Ablation System is not intended for use in cardiac procedures

Quantity: 4,920 units

Why Was This Recalled?

Medtronic is voluntarily recalling specific item codes and production lots of Covidien Emprint" Percutaneous Antenna with Thermosphere" Technology due to the potential for the generator to shut down in the precence of high temperature measurements in the Emprint" Percutaneous Antenna.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Covidien Medical Products (Shanghai) Manufacturing L.L.C.

Covidien Medical Products (Shanghai) Manufacturing L.L.C. has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report