Codman Certas Programmable Valves Recalled for Potential Malfunction
Codman & Shurtleff is recalling 369 Certas Programmable Valves used for hydrocephalus because they may not operate properly.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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, FDA Class II recalls involving significant injury or structural defects in medical devices are rated as Severe (4).
Plain-English summary
Codman & Shurtleff, Inc. is recalling 369 units of the Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Catheter and Accessories (Product Code: 82-8805). 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 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 SiphonGuard Device, Catheter and Accessories Product Code: 82-8805 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF…
- Manufacturer
- Codman & Shurtleff, Inc.
- Hazard
- Affected units
- 369
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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