Codman Certas Valve Recall Clarifies Pressure Specification in Instructions for Use
Codman & Shurtleff 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 explicitly states the purpose is to clarify a specification in the Instructions for Use and does not report any illnesses or injuries. Per the rubric, when no illnesses are reported and the hazard is theoretical or documentation-related, the score is capped at 3, but given the nature of a clarification recall without reported harm, it aligns with Moderate (2) as a precautionary/documentation issue rather than a high-risk pathogen or mislabeling of a common allergen.
Plain-English summary
Codman & Shurtleff, Inc. is recalling 9,498 Codman Certas Programmable valves, product code 82-8800. These implantable devices are used to provide constant intraventricular pressure and drainage of cerebrospinal fluid for the management of hydrocephalus.
The recall is being conducted to clarify the pressure specification for the 'virtual off' (setting 8) as outlined in the product's Instructions for Use (IFU). The source text does not report any illnesses, injuries, or deaths associated with this recall.
The devices were distributed worldwide, including in the United States and numerous international countries. The source text does not provide specific instructions for consumers or healthcare providers on how to proceed, nor does it list specific lot numbers in the narrative text, though structured data indicates multiple lot numbers are involved.
The recalled product
- Product
- Codman Certas - In Line Valve Only; Product Code: 82-8800 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.
- 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: CLNCB1
- CMBBP1
- CMBCPN
- CMCBWG
- CMCC2V
- CMDCN8
- CMDDJN
- CMGB8H
- CMI<B21
- CMJCL8
- CMJCPW
- CMMCGR
- CMNBFB
- CMNBZJ
- CMNC8T
- CMNCYL
- CMPB4V
- CNBBCV
- CNCB6W
- CNCCPF
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.
See all 8 products in this recall →Related recalls
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