Events

Safety Alert for Innova™ Self-Expanding Stent System

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Boston Scientific 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
    2011-09-02
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20110902.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
    Fda class i recall: boston scientific innova™ self-expanding stent system fda has issued a class i recall on the boston scientific innova™ self-expanding stent system. a total of 72 products are affected and the manufacturer, boston scientific corporation, is conducting a recall of these products. the innova™ self-expanding stent system is indicated for the treatment of peripheral vascular lesions. the manufacturer has received 6 complaints involving no deployment or partial deployment of the innova stents. potential health hazard events resulting from this type of failure include increased procedure time, vessel wall injury, and emergency surgery to remove the partially deployed stent. this recall does not affect stents that have already been implanted, as the issue occurs during delivery of the stent. according to the local supplier, the affected products are not distributed in hong kong. for details, please refer to the fda link: http://www.Fda.Gov/safety/recalls/enforcementreports/ucm270461.Htm if you are in possession of the affected products, please contact your supplier for necessary actions.

Device

Innova™ Self-Expanding Stent System

Manufacturer

Boston Scientific Corporation
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DH