Codman Certas Programmable Valve In Line Valve with Catheter and… — Class II medical device recall Z-0859-2014
Terminated recall by Codman & Shurtleff, Inc., reported 2014-02-05, distributed nationwide. Codman Certas Programmable Valves used for hydrocephalus may not operate properly
| Recall number | Z-0859-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Codman & Shurtleff, Inc., Raynham, MA, United States |
| Recall initiated | 2013-05-16 |
| Classified | 2014-01-28 |
| Reported by FDA | 2014-02-05 |
| Terminated | 2015-06-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BR, CH, CZ, DE, ES, FI, FR, GB, IL, IT, NL, NO, PT, RU, SA, SE, SI, SK, TR, ZA |
| Quantity | 895 units |
| Lot numbers | CMBBP2 |
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 for recall
Codman Certas Programmable Valves used for hydrocephalus may not operate properly
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0859-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.