Events

Safety Alert for neuron max catheters

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
    2013-10-28
  • Event Date Posted
    2013-10-28
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131028.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 neuron max catheters medical device manufacturer, penumbra inc., has issued a medical device safety alert concerning neuron max catheters. the affected catalogue numbers are as follows: pnmd8f088804m - 8f 088 neuron max 088 delivery catheter 80/4 mp pnmd8f088904m - 8f 088 neuron max 088 delivery catheter 90/4 mp pnml6f088804m - 6f 088 neuron max long sheath 80/4 mp pnml6f088904m - 6f 088 neuron max long sheath 90/4 mp pnml6f0881004m - 6f 088 neuron max long sheath 100/4 mp the manufacturer has recently identified that, for some neuron max catheters, it is possible for the packaging mandrel to remain within the catheter during removal. when this occurs, the catheter tip can be damaged. this is due to reduced adherence of the mandrel to the packaging card. the manufacturer advises affected users to take the following preventive actions: follow the product instructions for use and remove the device carefully inspect the device prior use to detect any damage has occurred to the product during the removal from the packaging. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 28 october 2013.

Device

neuron max catheters
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Penumbra Neuron MAX Catheters
  • Manufacturer
    Penumbra Inc.

Manufacturer

Penumbra Inc.