Events

Recall of Device Recall The AXIUM DETACHABLE COIL SYSTEM

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Micro Therapeutics Inc, dba ev3 Neurovascular.

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
    50776
  • Event Risk Class
    Class 3
  • Event Number
    Z-0841-2012
  • Event Initiated Date
    2008-11-12
  • Event Date Posted
    2012-01-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-01-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=77161
  • 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
    Device, neurovascular embolization - Product Code HCG
  • Reason
    Ev3 neurovascular has identified an incorrect expiration date on the label of one lot of ev3 axium coils catalog qc-2-2-3d. this lot 5871057 shows an expiration date of 0211-04. the expiration date should read 2011-04. there are no functional issues with the coils in question as the appropriate expiration date is 2011.
  • Action
    ev3 Neurovascular sent a "NOTIFICATION OF RECALL" letter dated November 6, 2008 to all affected customers. The letter identifies the product, problem, and the actions to be taken by the customers. The letter instructs customers to stop use and segregate the affected product from inventory. A reply form was attached to the letter for customers to complete and fax to Customer Service at (763)398-7001. Customer Service will issue an RGA number for the return of the affected product. Contact the Quality Systems Manager at (949) 680-1305 for questions regarding this notice.

Device

Device Recall The AXIUM DETACHABLE COIL SYSTEM
  • Model / Serial
    Lot Number: 5871057
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of CA, CT, NE, NV, and WI. and the countries of Argentina, Brazil, Colombia, and Egypt.
  • Product Description
    Axium Detachable Coil System Model Number: QC-2-2-3D. || The AXIUM DETACHABLE COIL SYSTEM consists of a platinum embolization coil attached to a composite implant delivery pusher with a radiopaque positioning marker and a hand-held I.D. (instant detacher) which when activated detached the coil from the delivery pusher tip. Some of the AX IUM Detachable coils are enlaced with PGLA microfilaments or Nylon microfilaments. I.D. (instant detached) is sold separately.
  • Manufacturer
    Micro Therapeutics Inc, dba ev3 Neurovascular

Manufacturer

Micro Therapeutics Inc, dba ev3 Neurovascular
  • Manufacturer Address
    Micro Therapeutics Inc, dba ev3 Neurovascular, 9775 Toledo Way, Irvine CA 92618-1811
  • 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