Events

Recall of Penumbra System Reperfusion Catheter 032

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
    57166
  • Event Risk Class
    Class 1
  • Event Number
    Z-0428-2011
  • Event Initiated Date
    2010-10-25
  • Event Date Posted
    2010-11-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-06-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95518
  • 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
    Reperfusion catheter may fail at the mid-shaft joint and may break off. if the segment cannot be removed, it may result in blocked blood flow, requiring emergency medical treatment.
  • Action
    Penumbra issued an Urgent Voluntary Field Removal letter dated October 28, 2010 to consignees, identifying the affected device and actions to be taken by consignees. Customers were instructed to inspect their inventory for the affected product and quarantine it, pending return to Penumbra. Penumbra employees will contact customers to arrange return and replacement of affected units. Customers were also requested to complete and return a product identification form and return form to Penumbra within 5 business days. Customers can contact Penumbra at 1 510 748-3223 concerning this action.

Device

Penumbra System Reperfusion Catheter 032
  • Model / Serial
    Lot number F15020
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: 17 consignees in the US, including in the states of CA, FL, HI, ID, IL, KY, MA, MS, NJ, NY, PA, and TX, 1 in Canada and 21 in the EU countries of France, Germany, Hungary, Italy, Norway, Slovenia, Spain, and the United Kingdom.
  • Product Description
    Penumbra System Reperfusion Catheter 032, catalog number PSC032, lot number lot F15020, manufactured by Penumbra, Alameda, CA.
  • 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