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U.S. Department of Health and Human Services

Class 2 Device Recall CODMAN CERTAS Programmable Valve

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  Class 2 Device Recall CODMAN CERTAS Programmable Valve see related information
Date Initiated by Firm May 16, 2013
Date Posted January 29, 2014
Recall Status1 Terminated 3 on June 02, 2015
Recall Number Z-0859-2014
Recall Event ID 65179
510(K)Number K112156  K113526  
Product Classification Shunt, central nervous system and components - Product Code JXG
Product Codman Certas Programmable Valve In Line Valve with Catheter and Accessories
Product Code: 82-8801


Product Usage:
The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. The valve can be set to a choice of eight opening pressure settings for constant intraventricular perssure drainage of CSF. The CODMAN CERTAS Therapy Management System (TMS) allows the non-invasive reading or adjustment of the valve setting.
Code Information Lot Codes:  CMBBP2 CMCBLG CMDBHG CMFBB8 CMHDFW CMJCPY CMLBLW CMLCKP CMMBCY CMMC3F CMNBFC CMNCDW CMPB96 CNCCLK CNJBW0 CNJC4B CNJC4W CNKBWN CNKCL1 CNLBR3 CNLBZF CNMDM1 CNNCPL CNNDH4 CNPBRM CPBBGP CPBC97 CPBCRW CPCBHB CPCCMP CPDBYF CPBCVD CPDBYD  CPDBM1 CMBCB2 CMCBLH CMDBHF CMGBL5 CMJCMC CMLBLY CMNBZK CNDCV1 CNHC8N CNKB41 CNLBR5 CNMB2Z CNMDNN CNNCWG CNPB1Y CNPCLT CPBCRY CPFBK1  CLPCM9 CMBBB2 CMBBB3 CMDBHD CMDCN7 CMDDJT CMFBNK CMFBNL CMNBZG CNDCP3 CNGBK5 CNHCZP CNJB1F CNJC4R CNJCMP CNKB0Y CNLCL0 CNMCYY CNMDNJ CNNDH0 CNPBRK CNPCLW CPBBGR CPCCBC CPCCML CPDCC2 
Recalling Firm/
Manufacturer		 Codman & Shurtleff, Inc.
325 Paramount Drive
Raynham MA 02767
For Additional Information Contact Same
508-880-8100
Manufacturer Reason
for Recall		 Codman Certas Programmable Valves used for hydrocephalus may not operate properly
FDA Determined
Cause 2		 Device Design
Action Codman issued an Urgent Notice dated May 16, 2013, to all affected customers. The letter identifed the affected product, problem and actions to be taken. Mitigation instructions are provided and if not followed or are not successful, either issue could lead to symptoms associated with under- or over-drainage. Units not implanted are to be returned. A U.S Acknowledgement Form and fax are requested to be completed and faxed to: 1-888-943-4193, or e-mail the form to codman8894@stericycle.com. If you have any questions on concerns in regards to this recall, please contact your Codman Representative or Stericycle at 1-888-943-2395.
Quantity in Commerce 895 units
Distribution Worldwide Distribution - US Nationwide, Australia, Austria, Belgium, Brazil, Switzerland, Czech Republic, Germany, Spain, Finland, France, Great Britain, Israel, Italy, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Sweden, Slovenia, Slovakia, Turkey, South Africa, and UK.
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 = MEDOS INTERNATIONAL SARL
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