Codman Certas Programmable Valves Recalled for Potential Malfunction
Codman & Shurtleff is recalling 895 Certas Programmable Valves used for hydrocephalus because they may not operate properly.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, an FDA Class II recall involving a significant injury or structural defect in a medical device warrants a score of 4 (Severe).
Plain-English summary
Codman & Shurtleff, Inc. is recalling 895 units of the Codman Certas Programmable Valve In Line Valve with Catheter and Accessories (Product Code: 82-8801). The recall is due to a risk that the valves may not operate properly.
The Codman Certas Programmable Valve is an implantable device used to provide constant intraventricular pressure and drainage of cerebrospinal fluid (CSF) for the management of hydrocephalus. The device allows for non-invasive reading or adjustment of the valve setting via the Codman Certas Therapy Management System.
The affected units were distributed worldwide, including in the United States, Australia, Austria, Belgium, Brazil, Switzerland, and numerous other countries. Patients with these implanted devices should contact their healthcare provider for evaluation and appropriate management.
The recalled product
- Product
- Codman Certas Programmable Valve In Line Valve with Catheter and Accessories Product Code: 82-8801 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for th
- Manufacturer
- Codman & Shurtleff, Inc.
- Affected units
- 895
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Codman & Shurtleff, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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