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Recall Observatory FDA recall evidence

Device product

Codman Certas Programmable Valve In Line Valve with Unitized BactiSeal Catheter and Accessories Product Code: 82-8803 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-0860-2014

May 16, 2013

Class II

Product summary

Firm
Codman & Shurtleff, Inc.
Event
Event 65179
Status
Terminated
Classification
Class II
Quantity
431 units
Official record key
device-enforcement:Z-0860-2014

Official wording

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

Code information: Lot Codes: CLPCM9 CMBBB2 CMBBB3 CMDBHD CMDCN7 CMDDJT CMFBNK CMFBNL CMNBZG CNDCP3 CNGBK5 CNHCZP CNJB1F CNJC4R CNJCMP CNKB0Y CNLCL0 CNMCYY CNMDNJ CNNDH0 CNPBRK CNPCLW CPBBGR CPCCBC CPCCML CPDCC2

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