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Recall Observatory FDA recall evidence

Device product

CODMAN CERTAS Programmable Valves, central nervous system shunt, models as follows: 82-8800 In Line Valve Only 82-8801 In Line Valve with Catheter and Accessories 82-8802 In Line Valve with Unitized Catheter and Accessories 82-8803 In line Valve with Unitized BACTISEAL Catheter and Accessories 82-8804 In Line Valve only with SIPHONGUARD Device 82-8805 In Line Valve with SIPHONGUARD Device, Catheter and Accessories 82-8806 In Line Valve with SIPHONGUARD, Unitized Catheter and Accessories 82-8807 In Line Valve with SIPHONGUARD Device, Unitized BACTISEAL Catheter and Accessories 82-8850 Certas Therapeutic Management System

Z-1468-2014

December 13, 2013

Class II

Product summary

Firm
Codman & Shurtleff, Inc.
Event
Event 67793
Status
Terminated
Classification
Class II
Quantity
9,445 units
Official record key
device-enforcement:Z-1468-2014

Official wording

Reason: Ensuring all customers have the tools to assist in verifying the setting of the valve on x-ray images and the location and orientation of implanted CODMAN CERTAS Programmable Valves.

Code information: All serial numbers

Distribution pattern: Nationwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Ensuring all customers have the tools to assist in verifying the setting of the valve on x-ray images and the location and orientation of implanted CODMAN CERTAS Programmable Valves.