Events

Recall of Device Recall Penumbra Neuron Select Catheter

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
    52963
  • Event Risk Class
    Class 1
  • Event Number
    Z-2049-2009
  • Event Initiated Date
    2009-07-02
  • Event Date Posted
    2009-09-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-01-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84353
  • 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
    Catheter, percutaneous - Product Code DQY
  • Reason
    Leakage-- due to a manufacturing error, some products may have a fold in the innermost layer, causing disruption in the layering process and may result in blow holds or exposed wire braids, which may result in further damage.
  • Action
    Penumbra, Inc. initiated Recall activities on May 29, 2009. The Firm notified consignees via telephone and email of the problem and asked them to return the product to Penumbra. For further information, contact Penumbra, Inc. at 1-510-748-3223.

Device

Device Recall Penumbra Neuron Select Catheter
  • Model / Serial
    Catalog Number: PNS5f130H1; Lot Number: F15174.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US (IA, NJ, NY and VA), and Canada.
  • Product Description
    Penumbra Neuron 5F Select Catheter, Neuro Deliver/Intracranial Access System Catheter, manufactured by Penumbra, Inc., Alameda, CA. || Intended 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