Events

Recall of Device Recall Pipeline Embolization Device

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
    65810
  • Event Risk Class
    Class 2
  • Event Number
    Z-2045-2013
  • Event Initiated Date
    2013-07-19
  • Event Date Posted
    2013-08-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-10-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120283
  • 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
    Intracranial aneurysm flow diverter - Product Code OUT
  • Reason
    Covidien neurovascular has initiated the recall of several lots of pipeline embolization device (ped) because the instructions for use (ifu) do not include the following contraindication: patients in whom a pre-existing stent is in place in the parent artery at the target aneurysm location. additionally, the designation of aspirin and clopidogrel was missing from the following contraindication ".
  • Action
    Covidien sent an Customer Notification letter dated July 19, 2013, to all affected customers who received affected lots of Pipeline Embolization Device (PED). The customer notification letter informed the customers of the problems identified and the actions to be taken. Customer are instructed to reply and fax response form to Covidien Customer Service at (763) 398-7001. Customers are instructed that Customer Service will issue an RGA number for the return of the affected product back to Covidien. Customers are also instructed that upon receipt of a Returned Goods Authorization (RGA) number, to write the RGA number on the FEDEX slip and send the product back to: Covidien Attention: Product Recall 14005 13th Ave Plymouth, MN 55441 Prepaid and preaddressed FEDEX slips are enclosed for their convenience. Once Covidien receives the returned units, product replacement units will be shipped directly to customers. Local Covidien Neurovascular representative is also available to assist them in expediting the exchange of product. Customers with any questions, are instructed to call (949) 839-3700.

Device

Device Recall Pipeline Embolization Device
  • Model / Serial
    Model/Lot Numbers:  FA-71400-25 / 9747602  FA-77350-18 / 9749412  FA-77400-20 / 9759088 FA-71500-35 / 9747604  FA-77375-16 / 9744487  FA-77425-16 / 9752788 FA-77300-16 / 9757068  FA-77375-20 / 9757065  FA-77425-20 / 9744123 FA-77325-14 / 9759141  FA-77400-14 / 9757233  FA-77425-20 / 9752438 FA-77325-16 / 9753034  FA-77400-14 / 9768698  FA-77450-18 / 9753033 FA-77325-16 / 9757024  FA-77400-16 / 9743468  FA-77475-20 / 9752787 FA-77325-18 / 9759560  FA-77400-18 / 9751579  FA-77500-20 / 9750678 FA-77350-16 / 9752785  FA-77400-20 / 9755707
  • Product Classification
    Neurological Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    US Distribution including the states of AZ, KY, MO, NC, GA, WI, OR, FL, NY, CA, IL, TN, NV, TX, CO, MA, IA, UT and VA.
  • Product Description
    Pipeline Embolization Device (PED) || The Pipeline Embolization Device is indicated for the endovascular treatment of adults (22 years of age and older) with large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments.
  • 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