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Recall Observatory FDA recall evidence

Device product

Codman Certas Programmable Valve In Line Valve Only Product Code: 82-8800 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-0858-2014

May 16, 2013

Class II

Product summary

Firm
Codman & Shurtleff, Inc.
Event
Event 65179
Status
Terminated
Classification
Class II
Quantity
1460 units
Official record key
device-enforcement:Z-0858-2014

Official wording

Reason: Codman Certas Programmable Valves used for hydrocephalus may not operate properly

Code information: Lot Codes: CLNCB1 CMBBP1 CMBCPN CMCBWG CMCC2V CMDCN8 CMDDJN CMGB8H CMJCL8 CMJCPW CMKB21 CMMCGR CMNBFB CMNBZJ CMNC8T CMNCYL CMPB4V CNCCPF CNDBCW CNDBRH CNDCJ2 CNFCK7 CNGBG0 CNGBK2 CNHCKH CNHCZN CNJBW5 CNJBWZ CNJC38 CNJC4K CNJCD3 CNJCFR CNJCMN CNKBWP CNKCC8 CNKCL3 CNLBR6 CNLCL3 CNLCW3 CNNCWF CNPB1R CNPBRH CNPCLR CPBC96 CPBCCR CPBCRV CPCBG9 CPCCMK CPDBYC CPDC07 CPDCC7 CNBBCV CNCB6W CNGBRY CNHB95 CNNDCK CNPB1T CNPBML CPBB3G CPCBG8 CPCCBH CPCCM1 CPCCMZ CPFBKP

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

    reason.no_named_rule · v1.0.0

    Codman Certas Programmable Valves used for hydrocephalus may not operate properly