Device product
Codman Certas Programmable Valve In Line Valve with Siphonguard, Unitized Catheter and Accessories Product Code: 82-8806 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.
Z-0863-2014
Product summary
- Event
- Event 65179
- Status
- Terminated
- Classification
- Class II
- Quantity
- 409 units
- Official record key
device-enforcement:Z-0863-2014
Official wording
Reason: Codman Certas Programmable Valves used for hydrocephalus may not operate properly
Code information: Lot Codes: CMJCMD CMBC2Z CMDB7C CMJC49 CMBCPR CMCC2T CMDBHC CMLBLZ CMMB14 CNDBCY CNDCV2 CNJCFT CNKBH6 CNLB57 CNMDNL CNNCWD CNPB1Z CPBB3J CPBDBB CPCCM0 CPDBYK
Distribution pattern: Worldwide Distribution - US Nationwide, Australia, Austria, Belgium, Brazil, Switzerland, Czech Republic, Germany, Spain, Finland, France, Great Britain, Israel, Italy, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Sweden, Slovenia, Slovakia, Turkey, South Africa, and UK.
Derived failure modes
-
Unknown
Codman Certas Programmable Valves used for hydrocephalus may not operate properly