Events

Recall of Device Recall InterGard Knitted Collagen Coated Vascular prostheses

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
    54562
  • Event Risk Class
    Class 2
  • Event Number
    Z-1427-2010
  • Event Initiated Date
    2009-12-09
  • Event Date Posted
    2010-04-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-04-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88717
  • 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, of 6mm and greater diameter - Product Code DSY
  • Reason
    Packaging was mislabeled.
  • Action
    InterVascular SAS issued a "Recall Notification - Product Recall RC 020" notification dated January 29, 2009 to the sole consignee. The consignee had previously been notified by phone and all affected product had been segregated. For further information, contact InterVascular SAS at +33 442 08 77 84.

Device

Device Recall InterGard Knitted Collagen Coated Vascular prostheses
  • Model / Serial
    Serial Number: 40246657, Lot number: 09M03.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution - Arizona.
  • Product Description
    InterGard Knitted Collagen Coated Vascular prostheses, Catalog number: IGK1206. InterVascular SAS, France. || Indicated for surgical repair, bypass or replacement of arteries in the treatment of aneurysmal and occlusive disease of the abdominal aorta, visceral arteries, and peripheral arteries.
  • 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