Events

Recall of SOFT-VU ANGIOGRAPHIC CATHETERS - OMNI FLUSH

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

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
    62165
  • Event Risk Class
    I
  • Event Initiated Date
    2016-07-08
  • 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
    It was reported to stryker sustainability solutions that the tip of two angiographic catheter's model # 10732203 broke off prior to being used on the patient. during the complaint investigation visual inspection confirmed that each device had fractured near the distal tip.

Device

SOFT-VU ANGIOGRAPHIC CATHETERS - OMNI FLUSH
  • Model / Serial
    Model Catalog: 10732203 (Lot serial: 253202)
  • Product Description
    RE-STERILZED ANGIODYNAMICS SOFT-VU OMNI FLUSH ANGIOGRAPHIC CATHETER
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

STRYKER CANADA LP
  • Manufacturer Address
    HAMILTON
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    HC