Events

Safety Alert for Hydrofinity Hydrophilic Guidewire

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

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
    2014-06-19
  • Event Date Posted
    2014-06-19
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140619a.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
    Medical device safety alert: nitinol devices & components hydrofinity hydrophilic guidewire the united states food and drug administration (fda) has issued a medical device safety alert concerning hydrofinity hydrophilic guidewires, manufactured by nitinol devices & components, inc. the manufacturer announced a voluntary recall of the hydrofinity hydrophilic guidewires due to two reports of the outer polymer jacket to the core wire being damaged when the guidewire was withdrawn rapidly through certain delivery catheters and ten cases where the product was less severely damaged during use. damage to the jacket can result in embolization of polymer, potentially leading to vessel occlusion or damage. vessel occlusion may necessitate surgical intervention to resolve. two cases were reported where the polymer jacket separated from the device and embolized. one case required surgical intervention. for details, please refer to the fda websites:http://www.Fda.Gov/safety/recalls/ucm401753.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 june 2014.

Device

Hydrofinity Hydrophilic Guidewire

Manufacturer

Nitinol Devices & Components