Codman Certas Programmable Valves Recalled for Missing Verification Tools
Codman & Shurtleff is recalling 9,445 units of Certas Programmable Valves to ensure customers have tools to verify valve settings and location on x-ray images.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a missing verification tool rather than a direct defect causing injury, fitting the criteria for a moderate risk or precautionary recall.
Plain-English summary
Codman & Shurtleff, Inc. is recalling 9,445 units of CODMAN CERTAS Programmable Valves, central nervous system shunts. The recall includes various models, such as in-line valves with or without catheters and accessories, and the Certas Therapeutic Management System. All serial numbers are affected, and the products were distributed nationwide.
The recall is being conducted to ensure that all customers have the necessary tools to assist in verifying the setting of the valve on x-ray images, as well as the location and orientation of the implanted valves. The source text does not specify a defect in the valve mechanism itself, but rather a lack of verification tools for the customer.
Healthcare providers and patients should contact Codman & Shurtleff, Inc. for further instructions regarding the recall and the provision of the appropriate verification tools.
The recalled product
- 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…
- Manufacturer
- Codman & Shurtleff, Inc.
- Affected units
- 9,445
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All serial numbers
Distribution
Distributed nationwide across the United States.
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