BEUDAMED
    FDA Enforcement Class II Terminated

    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.

    Recall: Z-0863-2014 · Reported February 5, 2014

    Enforcement

    Recall Number
    Z-0863-2014
    Event ID
    65179
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Codman & Shurtleff, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 5, 2014
    Initiation Date
    May 16, 2013
    Classification Date
    January 28, 2014
    Termination Date
    June 2, 2015
    Address
    325 Paramount Drive, Raynham, MA, 02767, United States

    Description

    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.

    Reason

    Codman Certas Programmable Valves used for hydrocephalus may not operate properly

    Code Info

    Lot Codes: CMJCMD CMBC2Z CMDB7C CMJC49 CMBCPR CMCC2T CMDBHC CMLBLZ CMMB14 CNDBCY CNDCV2 CNJCFT CNKBH6 CNLB57 CNMDNL CNNCWD CNPB1Z CPBB3J CPBDBB CPCCM0 CPDBYK

    Distribution

    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.

    Quantity

    409 units