Z-1187-2016Class II

Short Percutaneous Antenna with Thermosphere" Technology Standard Percutaneous Antenna with Thermosphere"...

Name: Z-1187-2016 Short Percutaneous Antenna with Thermosphere" Technology Standard Percutaneous Antenna with Thermosphere"...
Creator: Covidien Medical Products (Shanghai) Manufacturing L.L.C.
Published: 2016-02-23
License: https://open.fda.gov/license/

Covidien Medical Products (Shanghai) Manufacturing LLC / initiated 2016-02-23 / Terminated / root cause: manufacturing process

FDA source

Covidien Medical Products (Shanghai) Manufacturing L.L.C. began a recall of Short Percutaneous Antenna with Thermosphere" Technology Standard Percutaneous Antenna with Thermosphere" Technology; The product is packaged in a blister with... on 2016-02-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1187-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-23
Posted: 2016-03-17
Terminated: 2017-06-21
Recalling firm: Covidien Medical Products (Shanghai) Manufacturing LLC
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
Product code: NEY System, Ablation, Microwave And Accessories
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Medtronic sent an Urgent Medical Device Recall letter dated February 23, 2016 to all affected customers via Federal Express or Certified Mail. The letter identified the affected product, problem and actions. Customers were advised to quarantine and discontinue use of the affected product and to Return product. For questions or concerns, contact your Medtronic representative or Customer Service at (800) 882-5878.
Quantity in commerce: 4,920 units
Distribution: Worldwide Distribution - US Nationwide, VA/govt/military consignees.
Product codes and lots: Model Numbers: CA15L1, CA20L1 and CA30L1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1187-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1187-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-17

Product code NEY

K133821Class IIEmprint Ablation SystemCovidien, LLC / cleared 2014-04-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)