Events

Recall of Device Recall Covidien Emprint Ablation System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Covidien Medical Products (Shanghai) Manufacturing L.L.C..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    73438
  • Event Risk Class
    Class 2
  • Event Number
    Z-1187-2016
  • Event Initiated Date
    2016-02-23
  • Event Date Posted
    2016-03-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-06-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144214
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, ablation, microwave and accessories - Product Code NEY
  • 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.
  • 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.

Device

Device Recall Covidien Emprint Ablation System
  • Model / Serial
    Model Numbers: CA15L1, CA20L1 and CA30L1
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide, VA/govt/military consignees.
  • 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
  • Manufacturer
    Covidien Medical Products (Shanghai) Manufacturing L.L.C.

Manufacturer

Covidien Medical Products (Shanghai) Manufacturing L.L.C.
  • Manufacturer Address
    Covidien Medical Products (Shanghai) Manufacturing L.L.C., Building 10 789 Puxinglu, Pujiang, Minhang, Shanghaishi China
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA