CLASS II Device recall · Reported 23 Mar 2016 · FDA Enforcement Report

Short Percutaneous Antenna with Thermosphere" Technology recalled

Covidien Medical Products (Shanghai) Manufacturing is recalling Short Percutaneous Antenna with Thermosphere" Technology Standard Percutaneous Antenna, distributed nationwide in the US. The recall was initiated on 23 Feb 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Numbers: CA15L1, CA20L1 and CA30L1

Quantity recalled4,920 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1187-2016
FDA event ID: 73438
Recalling firm: Covidien Medical Products (Shanghai) Manufacturing, Shanghaishi
Classification: Class II
Status: Terminated
Recall initiated: 23 Feb 2016
FDA classified: 17 Mar 2016
Reported: 23 Mar 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Temperature Abuse
Device type: Surgical Instruments

Timeline

23 Feb 2016	Recall initiated by company
17 Mar 2016	Classified by FDA	+23 days
23 Mar 2016	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.

Product as listed by the FDA

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

Where it was distributed

Worldwide Distribution - US Nationwide, VA/govt/military consignees.

Nationwide Virginia

Questions about this recall

Why was it recalled?

Which lots are affected?

Model Numbers: CA15L1, CA20L1 and CA30L1

Where was it sold?

Worldwide Distribution - US Nationwide, VA/govt/military consignees.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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