FDA Device recall Z-0858-2014
Codman Certas Programmable Valve In Line Valve Only Product Code: 82-8800 Product Usage: The CODMAN CERTAS Programmable Valve is an implant…
- 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 Product Code: 82-8800 Product Usage: The CODMAN CERTAS Programmable Valve is an implant… 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-0858-2014 |
| 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 Product Code: 82-8800 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: CLNCB1 CMBBP1 CMBCPN CMCBWG CMCC2V CMDCN8 CMDDJN CMGB8H CMJCL8 CMJCPW CMKB21 CMMCGR CMNBFB CM…Lot Codes: CLNCB1 CMBBP1 CMBCPN CMCBWG CMCC2V CMDCN8 CMDDJN CMGB8H CMJCL8 CMJCPW CMKB21 CMMCGR CMNBFB CMNBZJ CMNC8T CMNCYL CMPB4V CNCCPF CNDBCW CNDBRH CNDCJ2 CNFCK7 CNGBG0 CNGBK2 CNHCKH CNHCZN CNJBW5 CNJBWZ CNJC38 CNJC4K CNJCD3 CNJCFR CNJCMN CNKBWP CNKCC8 CNKCL3 CNLBR6 CNLCL3 CNLCW3 CNNCWF CNPB1R CNPBRH CNPCLR CPBC96 CPBCCR CPBCRV CPCBG9 CPCCMK CPDBYC CPDC07 CPDCC7 CNBBCV CNCB6W CNGBRY CNHB95 CNNDCK CNPB1T CNPBML CPBB3G CPCBG8 CPCCBH CPCCM1 CPCCMZ CPFBKP |
|---|
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-0858-2014%22
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