Events

Recall of ACIST ANGIOGRAPHIC SYSTEM - DISPOSABLE SET

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BRACCO DIAGNOSTICS 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
    26182
  • Event Risk Class
    II
  • Event Initiated Date
    2009-05-13
  • 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
    The manufacturer has received field reports of a bulge and leaks on the side of the 2.5" high-pressure tubing of bt2000 kits during a procedure which can result in unsatisfactory performance of the product.

Device

ACIST ANGIOGRAPHIC SYSTEM - DISPOSABLE SET
  • Model / Serial
    Model Catalog: BT2000 (Lot serial: 3168H)
  • Product Description
    ACIST ANGIOGRAPHIC SYSTEM-MANIFOLD KIT
  • Manufacturer
    BRACCO DIAGNOSTICS CANADA INC.

Manufacturer

BRACCO DIAGNOSTICS CANADA INC.
  • Manufacturer Address
    VAUGHAN
  • Manufacturer Parent Company (2017)
    Bracco Spa
  • Source
    HC