Recall Z-1187-2016— Covidien Medical Products (Shanghai) Manufacturing L.L.C.

Name: FDA recall Z-1187-2016
Creator: U.S. Food and Drug Administration
Published: 2016-02-23

Class II · Terminated

Class II FDA medical device recall by Covidien Medical Products (Shanghai) Manufacturing L.L.C., initiated 2016-02-23, terminated 2017-06-21. It names one FDA 510(k) clearance: K133821. Product: 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. Reason: 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..

Recalling firm: Covidien Medical Products (Shanghai) Manufacturing L.L.C.
Classification: Class II
Status: Terminated
Initiated: 2016-02-23
Terminated: 2017-06-21
Firm location: Shanghaishi, China

510(k) clearances named in this recall

1 on FDA's record

K133821 — EMPRINT ABLATION SYSTEMCovidien, LLC·cleared 2014-04-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.