FDA Device recall Z-0864-2014
Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Unitized Bactiseal Catheter and Accessories Product Code: 82-8807 P…
- 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 SiphonGuard Device, Unitized Bactiseal Catheter and Accessories Product Code: 82-8807 P… 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-0864-2014 |
| 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 SiphonGuard Device, Unitized Bactiseal Catheter and Accessories Product Code: 82-8807 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: CLPCNB CMBCPT CMCC2W CMDB6L CMDDJV CMKB24 CMLCKN CMMC3H CMNBZH CNCB6N CNCCLJ CNCCZ3 CNDB8C CN…Lot Codes: CLPCNB CMBCPT CMCC2W CMDB6L CMDDJV CMKB24 CMLCKN CMMC3H CMNBZH CNCB6N CNCCLJ CNCCZ3 CNDB8C CNDBRJ CNGBK4 CNHCZR CNJB1G CNJC4T CNJCMR CNKBZD CNLBVM CNLBZC CNMBFL CNNDH1 CNMBFM CNMDNK CNPBRL CNPCLV CPBBGT CNCCLH CNCCZ2 CNDB69 CNDCV0 CPBCR3 CPCBHC CPCBHD CPDCC3 CMMCGV CNBB11 CPBCR4 CPCCMN CPDBYL |
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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-0864-2014%22
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