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U.S. Department of Health and Human Services

Class 2 Device Recall Covidien Emprint Ablation System

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 Class 2 Device Recall Covidien Emprint Ablation Systemsee related information
Date Initiated by FirmFebruary 23, 2016
Date PostedMarch 17, 2016
Recall Status1 Terminated 3 on June 21, 2017
Recall NumberZ-1187-2016
Recall Event ID 73438
510(K)NumberK133821 
Product Classification System, ablation, microwave and accessories - Product Code NEY
ProductShort 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
Code Information Model Numbers: CA15L1, CA20L1 and CA30L1
FEI Number 3006451981
Recalling Firm/
Manufacturer		 Covidien Medical Products (Shanghai) Manufacturing L.L.C.
Building 10 789 Puxinglu
Pujiang, Minhang
Shanghaishi China
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionMedtronic 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 Commerce4,920 units
DistributionWorldwide Distribution - US Nationwide, VA/govt/military consignees.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = NEY
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