Events

Recall of Penumbra Neuron Delivery Catheter 070

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
    53426
  • Event Risk Class
    Class 1
  • Event Number
    Z-0001-2010
  • Event Initiated Date
    2009-09-22
  • Event Date Posted
    2009-10-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-11-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85486
  • 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
    Failure-- product can kink or ovalize, which may result in difficulty in catheter advancement or delivery of other devices and damage to catheter, which could lead to patient injury or death as a result of portions being retained in the patient.
  • Action
    The firm issued an Urgent Voluntary Field Removal Notice letter on 09/22/2009 to its consignees, asking them to inspect their stocks; remove affected product and place in quarantine for return to Penumbra Inc.; and complete and return the attached product identification / return form.

Device

Penumbra Neuron Delivery Catheter 070
  • Model / Serial
    Lot numbers F13733, F13751, F13773, F13799, F13817, F13826, F13856, F13865, F13880, F13899, F13934, F13960, F13970, F13971, F13980, F13997, F14007, F14028, F14045, F14046, F14047, F14048, F14102, F14103, F14150, F14182, F14183, F14427, F14482, F14560, and F14629.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, Canada, Hong Kong, Chile, the UK, Denmark, Norway, Sweden, Finland, Netherlands, Germany, Switzerland, Austria, and Spain.
  • Product Description
    Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. || 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