Events

Recall of NEURON DELIVERY CATHETER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PENUMBRA INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    48595
  • Event Risk Class
    III
  • Event Initiated Date
    2014-01-15
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Feedback from a hospital indicated that two neuron delivery catheter 053's received on an order were labeled pnd6f10512 (lot f37120) on the outer product box but the device labeling on the pouch inside the box read pnd6f1056m (lotf37125). it was determined that devices inside pouches are pnd6f10512 devices consistent with the outer product box label.

Device

NEURON DELIVERY CATHETER
  • Model / Serial
    Model Catalog: PND6F10512 (Lot serial: F37120)
  • Product Description
    Neuron Delivery Catheter 053
  • Manufacturer
    PENUMBRA INC.

Manufacturer

PENUMBRA INC.
  • Manufacturer Address
    ALAMEDA
  • Manufacturer Parent Company (2017)
    Penumbra, Inc.
  • Source
    HC