CODMAN CERTAS Programmable Valves, central nervous system shunt, models as follows: 82-8800 In...
FDA Device Recall #Z-1468-2014 — Class II — December 13, 2013
Recall Summary
| Recall Number | Z-1468-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 13, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Codman & Shurtleff, Inc. |
| Location | Raynham, MA |
| Product Type | Devices |
| Quantity | 9,445 units |
Product Description
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
Reason for Recall
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.
Distribution Pattern
Nationwide Distribution.
Lot / Code Information
All serial numbers
Other Recalls from Codman & Shurtleff, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1571-2014 | Class II | MedStream Programmable Infusion Pump, 20 mL, Pr... | Nov 10, 2015 |
| Z-1572-2014 | Class II | MedStream Programmable Infusion Pump, 40 mL, Pr... | Nov 10, 2015 |
| Z-1684-2015 | Class II | CODMAN 3000 Series Refill Set- Huber needles. ... | Mar 5, 2015 |
| Z-0091-2015 | Class II | Codman Lumbar Drainage Catheter Kit II with EDS... | Sep 15, 2014 |
| Z-0090-2015 | Class II | Codman EDS 3 Drainage System (no Ventricular Ca... | Sep 15, 2014 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.