Events

Safety Alert for FemoSeal Vascular Closure Systems

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

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
    2017-08-22
  • Event Date Posted
    2017-08-22
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170822a.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: terumo femoseal vascular closure systems medical device manufacturer, terumo medical corporation, has issued a safety alert concerning its femoseal vascular closure systems [product reference code: c11202]. the manufacturer is initiating a voluntary recall of select production lots of femoseal vascular closure systems in response to an increase in device related malfunction complaints. specifically, after the deployment of the inner locking disc, complaints allege that the button will not spring back as intended, preventing the outer locking disc from deploying and completing the procedure. when this failure occurs, options for the clinician include manual compression or surgical cut down. upon further review, devices associated with this complaint mode (approximately 1/600 per current complaint date) reflect the internal entrapment of the device’s suture assembly. suture entrapment prevents the proper actuation of the device to complete the surgical procedure. internal controls have been established in manufacturing to eliminate the potential for this defect. product replacement is on-going. according to the local supplier, the affected products are distributed in hong kong if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 22 august 2017.

Device

FemoSeal Vascular Closure Systems
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Terumo FemoSeal Vascular Closure Systems
  • Manufacturer
    Terumo Medical Corporation

Manufacturer

Terumo Medical Corporation