Codman Certas Valve Recalled to Clarify Pressure Specifications in Instructions
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 indicates the action is to clarify documentation (Instructions for Use) rather than address a reported injury or high-risk contamination, 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 Unitized BACTISEAL Catheter and Accessories. The recall is being conducted 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 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 CLPCM9, CMBBB2, and others listed in the agency documentation.
The devices were distributed worldwide, including to numerous US states and international locations such as Canada, Australia, and various European and Middle Eastern countries. 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 Unitized BACTISEAL¿ Catheter and Accessories; Product Code: 82-8803 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: CLPCM9
- CMBBB2
- CMBBB3
- CMDBHD
- CMDCN7
- CMDDJT
- CMFBNK
- CMFBNL
- CMNBZG
- CNDCP3
- CNGBK5
- CNHCZP
- CNJB1F
- CNJC4R
- CNJCMP
- CNKBOY
- CNLCLO
- CNMCYY
- CNMDNJ
- CNNDHO
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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