Events

Recall of Device Recall CODMAN CERTAS Programmable Valves

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
    67793
  • Event Risk Class
    Class 2
  • Event Number
    Z-1468-2014
  • Event Initiated Date
    2013-12-13
  • Event Date Posted
    2014-04-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-04-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126333
  • 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
    Shunt, central nervous system and components - Product Code JXG
  • Reason
    Ensuring all customers have the tools to assist in verifying the setting of the valve on x-ray images and the location and orientation of implanted codman certas programmable valves.
  • Action
    Codman Neuro issued notification packages dated 12/13/13 to Domestic Hospitals and international accounts. Specific letters and associated inclusion of the additional aids, include A) a valve setting verification guide with instructions for use with x-ray images, and B) a plastic valve cut out overlay). A response reply form was included to be completed and returned to confirm effectiveness of the notification.

Device

Device Recall CODMAN CERTAS Programmable Valves
  • Model / Serial
    All serial numbers
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution.
  • Product Description
    CODMAN CERTAS Programmable Valves, central nervous system shunt, models as follows: || 82-8800 In Line Valve Only || 82-8801 In Line Valve with Catheter and Accessories || 82-8802 In Line Valve with Unitized Catheter and Accessories || 82-8803 In line Valve with Unitized BACTISEAL Catheter and Accessories || 82-8804 In Line Valve only with SIPHONGUARD Device || 82-8805 In Line Valve with SIPHONGUARD Device, Catheter and Accessories || 82-8806 In Line Valve with SIPHONGUARD, Unitized Catheter and Accessories || 82-8807 In Line Valve with SIPHONGUARD Device, Unitized BACTISEAL Catheter and Accessories || 82-8850 Certas Therapeutic Management System
  • 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