Events

Safety Alert for 3d revascularization device

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

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
    2017-07-24
  • Event Date Posted
    2017-07-24
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170724.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: penumbra 3d revascularization device the united states food and drug administration (fda) has issued a medical device safety alert concerning penumbra 3d revascularization device, manufactured by penumbra inc. [lot numbers: c00644, c00645, c00646, c00717; distribution dates: 15 may 2017 to 7 june 2017; manufacturing dates: 21 march 2017 to 28 april 2017] the manufacturer is recalling the penumbra 3d revascularization device because there is a risk of the delivery wire breaking or separating during use. fractured pieces of the delivery wire could be left inside the patient’s brain bloodstream, and this or the attempts made to retrieve the fractured pieces, can make the stroke worse. this can also cause other serious adverse health consequences such as continued blockage of blood vessels, completion of the stroke, and death. affected users are advised to identify and remove any affected 3d revascularization devices from inventory and quarantine. for details, please refer to the fda websites: https://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm567913.Htm https://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm567990.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 24 july 2017.

Device

3d revascularization device
  • Model / Serial
  • Product Classification
    Neurological Devices
  • Product Description
    Medical Device Safety Alert: Penumbra 3D Revascularization Device
  • Manufacturer
    Penumbra Inc

Manufacturer

Penumbra Inc