Events

Safety Alert for Misago Peripheral Self-Expanding Stent System

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Terumo 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
    2016-08-12
  • Event Date Posted
    2016-08-12
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_201608012a.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 misago peripheral self-expanding stent system medical device manufacturer, terumo corporation, has issued a medical device safety alert concerning its misago peripheral self-expanding stent system. the affected devices are identified as follows:- product codes: all misago products starting with sf*f or sx-v lot number: all products on the market within the labeled expiration period (manufactured from september-2013 through august-2016) during the inspection process, the manufacturer identified a low occurrence rate of two types of non-conformances in comparison to the specifications as described in the regulatory applications: reduced diameter at one, or both ends of the stent due to incomplete self-expansion after release from the delivery catheter; and deformation of the stent strut shape due to the compression forces that are applied to compact, and mount the stent to the delivery catheter. according to the manufacturer, the body of clinical evidence as related to misago stents supports that clinical performance is not affected in that there are no new or additional complications, or adverse health consequences. the health hazard evaluation concluded that the nonconformity in the dimension (reduced diameter rat the ends of the stent), or in the stent shape (a bend or inconsistent alignment of the stent struts), will have no impact to safety, or effectiveness, of the product. therefore, there is no additional risk of serious health harm posed by these nonconforming products. the manufacturer has not received customer complaints, or adverse events, related to incomplete stent expansion, stent deployment failure, insufficient diameter, or stent deformation. product recall is ongoing. 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 12 august 2016.

Device

Misago Peripheral Self-Expanding Stent System
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Terumo Misago Peripheral Self-Expanding Stent System
  • Manufacturer
    Terumo Corporation

Manufacturer

Terumo Corporation