Events

Safety Alert for SUPER TORQUE® MB Angiographic Catheter

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Cordis.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2011-11-29
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111129a.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Field safety notice: cordis super torque® mb angiographic catheter medical device manufacturer, cordis, has issued a field safety notice related to a specific subgroup of cordis angiographic catheters, super torque® mb angiographic catheter. manipulation of the super torque® mb angiographic catheter under excessive friction due to interaction with other devices or while trapped in the vasculature, can lead to stretching or elongation of the catheter. stretching or elongation of the super torque® mb angiographic catheter during endovascular procedures could result in the marker bands moving along the catheter. in extreme cases, marker bands may come off the super torque® mb angiographic catheter and dislodge into the vascular system. movement of the marker bands can result in inaccurate reference and device sizing. dislodgement of the marker bands into the vascular system can result in additional intervention, embolism, thrombosis, or other vascular complications. the manufacturer is in the process of updating the product labeling. according to local supplier, the affected device has been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions.

Device

SUPER TORQUE® MB Angiographic Catheter
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Cordis SUPER TORQUER MB Angiographic Catheter
  • Manufacturer
    Cordis

Manufacturer

Cordis