FDA Device recall Z-2189-2014
Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Catheter and Accessories
- FDA Device
- Class II
- terminated
- Published 2014-08-20
On 2014-08-20 the FDA classified a Class II recall of Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Catheter and Accessories by Codman And Shurtleff, citing to clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2189-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-07-03 |
| Published | 2014-08-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Codman And Shurtleff |
| Distribution | AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY |
Product
Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Catheter and Accessories; Product Code: 82-8805 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.
Reason
To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
Identifiers
| code_info | Lot Numbers: CMBC2Y, CMDCN9, CMJC48, CMLC6D, CMNBFF, CMNCDY, CNCB6M, CNCCLB, CNCCZ4, CNDBRG, CNDCNB, CNHC8M, CNJC4P, C…Lot Numbers: CMBC2Y, CMDCN9, CMJC48, CMLC6D, CMNBFF, CMNCDY, CNCB6M, CNCCLB, CNCCZ4, CNDBRG, CNDCNB, CNHC8M, CNJC4P, CNKCL4, CNLCL1, CNMB8Y, CNMDMO, CNNDHY, CNPCLZ, CPBC99, CPBCRZ, CPCC27, CPDBYJ, CPDCKL |
|---|
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-2189-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.