Events

Recall of Device Recall VasoSeal ES

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Datascope Collagen Products Division.

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
    28389
  • Event Risk Class
    Class 3
  • Event Number
    Z-0762-04
  • Event Initiated Date
    2003-07-28
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-04-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31749
  • 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, Hemostasis, Vascular - Product Code MGB
  • Reason
    Kits are missing the temporary arteriotomy locator (tal) from the blister package.
  • Action
    Urgent Customer Advisory' Letter dated July 28, 2003.

Device

Device Recall VasoSeal ES
  • Model / Serial
    Lot No. 0605374, Exp. Date May 2005.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    The device was distributed throughout the US to 101 direct accounts. There was one distributor. There was one government account.
  • Product Description
    VasoSeal ES, Extravascular Security Vascular Closure Device, Catalog No. 76000. Class III (PMA P920004), sterile (via gamma irradiation) device is sold in cardboard shelf cartons containing 5 ea. individual kits. The individual kits are packaged in a blister with Tyvek lid within a heat sealed foil pouch and fiberboard envelope. The device delivers collagen to the surface of the femoral artery following diagnostic or interventional catherization procedures using 5-8 Fr. procedural sheaths. The device is indicated for use in sealing the femoral arterial puncture site.
  • Manufacturer
    Datascope Collagen Products Division

Manufacturer

Datascope Collagen Products Division
  • Manufacturer Address
    Datascope Collagen Products Division, 1300 MacArthur Blvd., Mahwah NJ 07430-0605
  • Source
    USFDA