Recall Z-0864-2014— Codman & Shurtleff, Inc.
Class II · Terminated
Class II FDA medical device recall by Codman & Shurtleff, Inc., initiated 2013-05-16, terminated 2015-06-02. It names 2 FDA 510(k) clearances: K113526, K112156. 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.
- Recalling firm
- Codman & Shurtleff, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-05-16
- Terminated
- 2015-06-02
- Firm location
- Raynham, MA, United States
510(k) clearances named in this recall
2 on FDA's record- K113526 — CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM
- K112156 — CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM, CODMAN CERTAS THERAPY MANAGEMENT SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 for recall
Codman Certas Programmable Valves used for hydrocephalus may not operate properly
Data sourced from openFDA. This site is unofficial and independent of the FDA.