Codman Certas Programmable Valves Recalled for Potential Malfunction
Codman & Shurtleff, Inc. is recalling 746 Codman Certas Programmable Valves because they may not operate properly. The devices are used to manage hydrocephalus.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves an implantable medical device that may not operate properly, representing a risk-of-harm product where specific injury or illness has not yet been reported in the source text.
Plain-English summary
Codman & Shurtleff, Inc. is recalling 746 units of the Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Unitized Bactiseal Catheter and Accessories (Product Code: 82-8807). The recall is being conducted because 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, Czech Republic, Germany, Spain, Finland, France, Great Britain, Israel, Italy, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Sweden, Slovenia, Slovakia, Turkey, South Africa, and the UK. Patients with these implanted devices should contact their healthcare provider for instructions on what to do next.
The recalled product
- Product
- Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Unitized Bactiseal Catheter and Accessories Product Code: 82-8807 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and dra
- Manufacturer
- Codman & Shurtleff, Inc.
- Affected units
- 746
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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