Reported Mar 23, 2016 · Terminated

Short Percutaneous Antenna with Thermosphere" Technology Standard Percutaneous Antenna with Thermosphere" Technology;…

Covidien Medical Products (Shanghai) Manufacturing LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Covidien Medical Products (Shanghai) Manufacturing L.L.C. · Building 10 789 Puxinglu · Shanghaishi · N/A

Is this the product you have?

  • 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 UsageThe 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
Lot codes and dates
  • Model Numbers
    • CA15L1
    • CA20L1 and CA30L1
Amount recalled
4,920 units

Where it was sold

  • Nationwide
  • VA

Why it was 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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 21, 2017 · Data as of Sep 19, 6:02 PM UTC

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