Events

Recall of Device Recall Penumbra 3D Revascularization Device

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
    77571
  • Event Risk Class
    Class 1
  • Event Number
    Z-2702-2017
  • Event Initiated Date
    2017-06-09
  • Event Date Posted
    2017-06-22
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156554
  • 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, thrombus retriever - Product Code NRY
  • Reason
    Penumbra has identified an issue in these four lots involving a raw material component of the delivery wire. this issue could result in breakage of the delivery wire, which could potentially lead to serious patient injury or death.
  • Action
    Penumbra sent an Urgent Voluntary Field Removal Notice dated June 9, 2017. Customers were instructed to inspect current inventory and remove any affected units for return. Customers were also instructed to return the response form. Penumbra has identified an issue in these four lots involving a raw material component of the delivery wire. This issue could result in breakage of the delivery wire, which could potentially lead to serious patient injury or death. Penumbra personnel will contact customers directly to arrange return of affected units and replacement of returned product at no charge to them. Customers with question should call 1-510-748-3288.

Device

Device Recall Penumbra 3D Revascularization Device
  • Model / Serial
    Lots C00644, C00645, C00646, C00717
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to the following states: AZ, CA, CO, FL, IN, MA, MI, MN, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, WV
  • Product Description
    Penumbra 3D Revascularization Device || It is indicated for used in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral-M1 and M2 segments) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
  • Manufacturer
    Penumbra Inc.

Manufacturer

Penumbra Inc.
  • Manufacturer Address
    Penumbra Inc., 1 Penumbra, Alameda CA 94502-7610
  • Manufacturer Parent Company (2017)
    Penumbra, Inc.
  • Source
    USFDA