Events

Recall of Device Recall Codman

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Codman & Shurtleff, 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
    58145
  • Event Risk Class
    Class 2
  • Event Number
    Z-2701-2011
  • Event Initiated Date
    2011-03-21
  • Event Date Posted
    2011-06-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98486
  • 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
    Intracranial neurovascular stent - Product Code NJE
  • Reason
    Mislabeled: one of the stick on stickers on the sterile pouch inside of the product box indicates the stent size to be 22mm in length, when in fact the product is 28mm in length.
  • Action
    Codman & Shurtleff, Inc.sent an "Urgent Medical Device Correction Notice" on March 21, 2011. The letter recommend the incorrect label be removed and discarded. There are 3 additional peel-off labels, 2 on the outer box and one on the pouch. All 3 of these contain the correct printed size information (28 mm) that can be used for applying to the inventory sheet, patient record or patient card, as needed. It is NOT required to return any of this product to Codman. Customer Service at 1-800-225-0460 or contact your local Codman Neurovascular Representative

Device

Device Recall Codman
  • Model / Serial
    Lot Numbers:  01420432, 01420851, 01421192, 01421315, 01421338, 01421601, 01421949, 01422123, 01422396, 01422401, 02420432, VV1419796
  • Product Classification
    Neurological Devices
  • Device Class
    HDE
  • Implanted device?
    Yes
  • Distribution
    Worldwide - Nationwide (USA), Canada, Korea.
  • Product Description
    CODMAN ENTERPRISE¿ Vascular Reconstruction Device and Delivery System 4.5mm x 28mm || Product code: ENF452812
  • Manufacturer
    Codman & Shurtleff, Inc.

Manufacturer

Codman & Shurtleff, Inc.
  • Manufacturer Address
    Codman & Shurtleff, Inc., 325 Paramount Drive, Raynham MA 02767
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA