Events

Recall of PROFILE 8FR. INTRA-AORTIC BALLOON CATHETERS WITH ACCESSORIES

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by DATASCOPE CORP..

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
    125998
  • Event Risk Class
    II
  • Event Initiated Date
    2001-11-19
  • 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
    Slight chance that the catheters may have a misalignment in the inner lumen path within the y-fitting component that could prevent the entire iab catheter from advancing over the wire during iab insertion.

Device

PROFILE 8FR. INTRA-AORTIC BALLOON CATHETERS WITH ACCESSORIES
  • Model / Serial
    Model Catalog: (Lot serial: )
  • Manufacturer
    DATASCOPE CORP.

Manufacturer

DATASCOPE CORP.
  • Manufacturer Address
    FAIRFIELD
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    HC