Events

Recall of Device Recall Penumbra Neuron Delivery Catheter 053

According to U.S. Food and Drug Administration, this recall involved a device in United States 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
    52989
  • Event Risk Class
    Class 2
  • Event Number
    Z-2313-2009
  • Event Initiated Date
    2009-07-01
  • Event Date Posted
    2009-09-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-11-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84414
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Percutaneous catheter - Product Code DQY
  • Reason
    Misbranding--some products may be identified with the wrong id band content 'neuron 6f 070' instead of 'neuron 6f delivery'.
  • Action
    Firm initiated its recall on June 30, 2009. Consignees notified on July 6 and 7, with follow up contact on July 7, 2009. Contact Penumbra Inc. at 1.510.618.3223, if there are any questions.

Device

Device Recall Penumbra Neuron Delivery Catheter 053
  • Model / Serial
    Catalog number PND6F11512M, lot number F14751
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA, FL, NC, MI, MO, VA, AZ, CT, IA, NY, and CO, Foreign: Germany and Australia.
  • Product Description
    Penumbra Neuron Delivery Catheter 053, 115 cm/12 cm-- MP, manufactured by Penumbra Inc., Alameda, CA || Percutaneous Catheter, indicated for the introduction of interventional devices into the peripheral, coronary and neuro vasculature.
  • Manufacturer
    Penumbra Inc.

Manufacturer

Penumbra Inc.
  • Manufacturer Address
    Penumbra Inc., 1351 Harbor Bay Pkwy, Alameda CA 94502-6541
  • Manufacturer Parent Company (2017)
    Penumbra, Inc.
  • Source
    USFDA