FDA Device recall Z-0861-2014
Codman Certas Programmable Valve In Line Valve only with SiphonGuard Device Product Code: 82-8804 Product Usage: The CODMAN CERTAS Programm…
- FDA Device
- Class II
- terminated
- Published 2014-02-05
On 2014-02-05 the FDA classified a Class II recall of Codman Certas Programmable Valve In Line Valve only with SiphonGuard Device Product Code: 82-8804 Product Usage: The CODMAN CERTAS Programm… by Codman And Shurtleff, citing codman Certas Programmable Valves used for hydrocephalus may not operate properly.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0861-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-05-16 |
| Published | 2014-02-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Codman And Shurtleff |
| Distribution | US |
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.
Reason
Codman Certas Programmable Valves used for hydrocephalus may not operate properly
Identifiers
| code_info | Lot Codes: CNMCDP CNMDM2 CNMDNG CNFCVJ CNHB96 CNHC8L CNHCZM CNHCZT CNJBWW CNJBWY CNJCFP CNJCG9 CNKB0R CN…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0861-2014%22
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