Codman Certas Valve Recall Clarifies Pressure Specification in Instructions for Use
Codman & Shurtleff, Inc. is recalling 9,498 Codman Certas valves to clarify the pressure specification for the virtual off setting in the product's 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, but the source text indicates the action is to clarify a specification in the Instructions for Use rather than to address a reported defect or injury, fitting the criteria for a moderate severity labeling/documentation issue.
Plain-English summary
Codman & Shurtleff, Inc. is recalling 9,498 units of the Codman Certas In Line Valve with SIPHONGUARD Device, Catheter and Accessories (Product Code: 82-8805). The recall is issued to clarify the pressure specification for the virtual off (setting 8) outlined in the product's Instructions for Use (IFU).
The affected devices are implantable valves used to provide constant intraventricular pressure and drainage of cerebrospinal fluid for the management of hydrocephalus. The recall covers specific lot numbers including CMBC2Y, CMDCN9, and others listed in the agency record.
The devices were distributed worldwide, including in the United States and various international markets. Patients and healthcare providers should consult the updated Instructions for Use regarding the pressure specifications for the virtual off setting.
The recalled product
- Product
- Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Catheter and Accessories; Product Code: 82-8805 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management…
- 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 (20)
- Lot Numbers: CMBC2Y
- CMDCN9
- CMJC48
- CMLC6D
- CMNBFF
- CMNCDY
- CNCB6M
- CNCCLB
- CNCCZ4
- CNDBRG
- CNDCNB
- CNHC8M
- CNJC4P
- CNKCL4
- CNLCL1
- CNMB8Y
- CNMDMO
- CNNDHY
- CNPCLZ
- CPBC99
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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