Events

Recall of FemoSeal Vascular Closure System

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Terumo Australia Pty Ltd.

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
    RC-2017-RN-01092-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-08-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01092-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Terumo medical corporation has received an increase in device related malfunction complaints for femoseal vascular closure systems. specifically, after the deployment of the inner locking disc, the complaints state that the button will not spring back as intended, preventing the outer locking disc from deploying and completing the procedure.An investigation by terumo has identified that the internal suture becomes entrapped as a result of operator miss-assembly during device manufacture and that this issue then only becoming visible midway through device deployment.
  • Action
    1. Review the urgent medical device recall notification and distribute to all staff working with this equipment. 2. Inform any facilities that may have received this product of the recall action. 3. Quarantine all product in the affected population, record the lot number and quantity on the Customer Response Form supplied with the Customer Letter 4. Place quarantined product in a secure location for return to Terumo Australia Regulatory Affairs Department. 5. Package and return all affected product via courier

Device

FemoSeal Vascular Closure System
  • Model / Serial
    FemoSeal Vascular Closure SystemAll non-expired productProduct Code: C11202Multiple Lot NumbersARTG Number: 263892
  • Manufacturer
    Terumo Australia Pty Ltd

Manufacturer

Terumo Australia Pty Ltd