Events

Recall of VASCU-GUARD PERIPHERAL VASCULAR PATCH WITH APEX PROCESSING

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BECTON DICKINSON CANADA INC..

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
    152741
  • Event Risk Class
    I
  • Event Initiated Date
    2016-08-05
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Baxter healthcare is issuing a safety alert in response to postmarketing reports received for the vascu-guard peripheral vascular patch for intraoperative or postoperative bleeding episodes which required additional clinical intervention. one report involved a case with a fatal outcome. at this point it is unknown whether there is any causal relationship between the device and the reported events.

Device

VASCU-GUARD PERIPHERAL VASCULAR PATCH WITH APEX PROCESSING
  • Model / Serial
    Model Catalog: VG-0108N (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: VG-0209N (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: VG-0110N (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: VG-0106N (Lot serial: >10 NUMBERS CONTACT MFR)
  • Product Classification
    Cardiovascular Devices
  • Product Description
    VASCU-GUARD PERIPHERAL VASCULAR PATCH
  • Manufacturer
    BECTON DICKINSON CANADA INC.

Manufacturer

BECTON DICKINSON CANADA INC.