Codman Certas Valve Recall Clarifies Pressure Specification in Instructions
Codman & Shurtleff is recalling 9,498 implantable valves to clarify the pressure specification for the virtual off setting in the Instructions for Use.
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 and involves a clarification of pressure specifications in the Instructions for Use, which aligns with the rubric for minor labeling or documentation issues.
Plain-English summary
Codman & Shurtleff, Inc. is recalling 9,498 units of the Codman Certas In Line Valve with Unitized Catheter and Accessories. The recall is initiated to clarify the pressure specification for the virtual off (setting 8) as outlined in the product's Instructions for Use (IFU).
The affected devices are implantable medical devices used to provide constant intraventricular pressure and drainage of cerebrospinal fluid for the management of hydrocephalus. The recall covers specific lot numbers, including CMBCB2, CMCBLH, and CMDBHF, among others.
The devices were distributed worldwide, including in the United States and various international markets. Consumers and healthcare providers should refer to the Instructions for Use for the clarified pressure specifications.
The recalled product
- Product
- Codman Certas - In Line Valve with Unitized Catheter and Accessories; Product Code: 82-8802 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of…
- Manufacturer
- Codman & Shurtleff, Inc.
- Hazard
- Affected units
- 9,498
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 (19)
- Lot Numbers: CMBCB2
- CMCBLH
- CMDBHF
- CMGBL5
- CMJCMC
- CMLBLY
- CMNBZK
- CNDCV1
- CNHC8N
- CNI<B41
- CNLBR5
- CNMB2Z
- CNMDNN
- CNNCWG
- CNPB1Y
- CNPCLT
- CPBCRY
- CPDBM1
- CPFBK1
Distribution
Part of a larger recall action
This product is one of 8 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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