Class 2 Device Recall Codman

• Date Initiated by Firm: September 15, 2014
• Date Posted: October 20, 2014
• Recall Status: Terminated on August 11, 2017
• Recall Number: Z-0090-2015
• Recall Event ID: 69262
• 510(K)Number: K061568
• Product Classification: Shunt, central nervous system and components - Product Code JXG
• Product: Codman EDS 3 Drainage System (no Ventricular Catheter); (External Drainage System); Catalog Number: 82-1731; Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated
• Code Information: All lots with expiration on or before August 2017 (2017-08)
• Recalling Firm/ Manufacturer: Codman & Shurtleff, Inc.; 325 Paramount Drive; Raynham MA 02767
• For Additional Information Contact: Same; 508-880-8000
• Manufacturer Reason for Recall: tubing within the system that drains CSF may leak or disconnect from the joints and may result in over- or under-drainage of CSF from the ventricular system or introduction of air into the ventricular system (pneumocephalus)
• FDA Determined Cause: Device Design
• Action: Codman Neuro sent an Urgent Notice dated September 12, 2014, to all affected customers via overnight mailing and OUS customers notified via email the week of September 15, 2014. Accounts were requested to isolate all inventory of the affected product and return to Stericycle at the following address: Stericycle 2670 Executive Drive, Suite A Attn: Event #8894 Indianapolis, IN 46241 For patients currently being managed with the EDS 3 System, the system should be replaced immediately. In the case where no substitute drainage system is immediately available, the EDS 3 System may continue to be used until an alternative product can be obtained. If you have any questions or concerns regarding this notification, please contact your local Codman Neuro Representative or Scientific and Medical Affairs at SciMedAffairs@its.jnj.com or (866) 685-7325. For questions regarding this recall call 508-880-8000.
• Quantity in Commerce: 93,558 units
• Distribution: Worldwide Distribution - USA (nationwide) and Internationally to: United Arab Emirates Argentina Austria Australia Aruba Belgium Bahrain Bolivia Brazil Bahamas Canada Switzerland Chile People's Republic of China Columbia Costa Rica Cyprus Czech Republic Germany Algeria Estonia Egypt Spain Finland France Gabon Great Britain French Guiana Greece Guatemala Hong Kong Croatia Hungary Ireland Israel India Iran Italy Jordan Kenya Kuwait Kazakhstan Lebanon Lithuania Luxembourg Latvia Mauritius Mexico Malaysia Mozambique New Caledonia Nigeria Netherlands Norway New Zealand Oman Panama Peru Poland Palestine Portugal Reunion Romania Serbia Russian Federation Rwanda Saudi Arabia Sweden Singapore Slovenia Slovakia Tunisia Turkey Trinadad And Tobago Taiwan Ukraine Uruguay Venezuela Mayotte South Africa
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JXG and Original Applicant = Codman & Shurtleff, Inc.