Events

Safety Alert for Macro Micro Subdural Electrodes

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Ad-Tech Medical Instrument 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
    2013-03-01
  • Event Date Posted
    2013-03-01
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130301.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: ad-tech medical instrument macro micro subdural electrodes the united states food and drug administration (fda) has posted a press release issued by medical device manufacturer, ad-tech medical instrument corporation, concerning its global recall of macro micro subdural electrodes. the recalled products were manufactured from june 2006 to march 2012, and distributed from 8 june 2006 to 14 march 2012. on 18 december 2012, the manufacturer initiated a recall of 115 macro micro subdural electrodes. there is a concern the microelectrodes are not flush with the silastic surface. as a result, there is the potential for abrasion of cortical brain tissue and the existence of fractured pieces remaining in the cortical tissue when the electrode is explanted, which may result in hemorrhage or damage to cortical fibers, leading to infarct or seizure activity. there has been one reported serious injury that may have been related to the use of the device. the manufacturer has notified its distributors and customers by recall letter and is arranging for the return of all available recalled product(s). for details, please visit the following fda website: http://www.Fda.Gov/safety/recalls/ucm341680.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 01 march 2013.

Device

Macro Micro Subdural Electrodes

Manufacturer

Ad-Tech Medical Instrument Corporation