FDA Device recall Z-0859-2014
Codman Certas Programmable Valve In Line Valve with Catheter and Accessories Product Code: 82-8801 Product Usage: The CODMAN CERTAS Program…
- 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 with Catheter and Accessories Product Code: 82-8801 Product Usage: The CODMAN CERTAS Program… 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-0859-2014 |
| 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 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.
Reason
Codman Certas Programmable Valves used for hydrocephalus may not operate properly
Identifiers
| code_info | Lot Codes: CMBBP2 CMCBLG CMDBHG CMFBB8 CMHDFW CMJCPY CMLBLW CMLCKP CMMBCY CMMC3F CMNBFC CMNCDW CMPB96 CN…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 |
|---|
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-0859-2014%22
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