FDA Medical Device Recalls (openFDA)
Codman & Shurtleff, Inc.: Codman Certas Programmable Valve In Line Valve only with SiphonGuard Device Product Code: 82-8804 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.
- Recall number
- Z-0861-2014
- Recalling firm
- Codman & Shurtleff, Inc.
- Product
- Codman Certas Programmable Valve In Line Valve only with SiphonGuard Device Product Code: 82-8804 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.
- Status
- Terminated
- Initiated
- 2013-05-16
- Posted
- 2014-01-29
- Terminated
- 2015-06-02
- Reason
- Codman Certas Programmable Valves used for hydrocephalus may not operate properly
- Root cause
- 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
- 1481 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.
- Lot, serial or model codes
- Lot Codes: CNMCDP CNMDM2 CNMDNG CNFCVJ CNHB96 CNHC8L CNHCZM CNHCZT CNJBWW CNJBWY CNJCFP CNJCG9 CNKB0R CNKBTR CNKCL0 CNKCL2 CNLBR2 CNLBZD CNMCDV CNMDM3 CNNCWC CNPB1W CNPBRJ CNPCLP CPBB39 CPBBGN CPBC98 CPBCKR CPBCKT CPCBG7 CPCCBG CPDBYH CPDC09 CPDCC4 CNBB13 CNCB6L CNDB8B CNDBVZ CNDCM9 CNHC8J CNHCKG CNJC39 CNJC4H CNJC4J CNJCB0 CNDCM8 CNKB42 CNFCVH CNHCZH CNJB98 CNLCW4 CNMBFK CNMCDW CNMDNH CNNCWH CNNDH2 CNNDH3 CNPB1V CPBB3H CPBCR0 CPCBG6 CPCCBD CPCCBF CPDBYG CPDCC6 CMMB1L CMBC2W CMDBHB CMDDJP CMDDJR CMKB22 CMLCKR CMMCR5 CMNBFD CMNCVP CMNCYM CMPB95 CMPBMD CNBBCZ CNCB4R CNCB61 CNMCDR CPCCMW
- 510(k) numbers
- ["K112156","K113526"]
- PMA numbers
- not on file
- Product code
- JXG
- Firm FEI
- 3002947440
- Firm city
- Raynham
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28