Events

Recall of Device Recall InterGard Knitted Collagen Coated Vascular prostheses and InterGard Woven Collagen Coated Va

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Intervascular S.A.S..

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
    54889
  • Event Risk Class
    Class 2
  • Event Number
    Z-1439-2010
  • Event Initiated Date
    2009-12-09
  • Event Date Posted
    2010-04-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-04-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89385
  • 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
    Prosthesis, vascular graft - Product Code DSY
  • Reason
    The external lid of intervascular's prosthesis has a cut in it which may compromise package integrity and therefore sterility.
  • Action
    The firm sent recall letters to all customers on December 9, 12009. Calls had been made prior to the letter being sent. Because all product was recovered, no additional questions are anticipated.

Device

Device Recall InterGard Knitted Collagen Coated Vascular prostheses and InterGard Woven Collagen...
  • Model / Serial
    Product Reference Serial Number Lot number IGW1206 40199297 09J17 IGK2412 40200277 09J17  40200412 09J17 IGK0018-40 40200310 09J17 IGW0008-30 40199072 09J17
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution went to one distributor in Arizona. Also Chile, France, Germany, Hong Kong, Poland and Turkey.
  • Product Description
    InterGard Knitted Collagen Coated Vascular prostheses marketed under 510(k) # K964625; || InterGard Woven Collagen Coated Vascular prostheses marketed under 510(k} #K970843 and K984294.
  • Manufacturer
    Intervascular S.A.S.

Manufacturer

Intervascular S.A.S.
  • Manufacturer Address
    Intervascular S.A.S., Zone Industrielle Athelia I, La Ciotat Cedex France
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    USFDA