The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0977-2025·Announced 2025-01-29

Programmable Valve Device Recalled Due to Incorrect Product Description Labels

CODMAN CERTAS Plus Programmable Valve (Model 828810) units were distributed with incorrect product descriptions on labels. 132 units affected across multiple U.S. states and international locations.

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: This FDA Class II recall involves a labeling discrepancy with no reported injuries or illnesses. The issue is a documentation error rather than a functional or structural device defect, meeting the rubric criteria for minor labeling errors.

Plain-English summary

The FDA has issued a recall for CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only (Model 828810), an implantable device designed to manage hydrocephalus by providing constant intraventricular pressure and cerebrospinal fluid (CSF) drainage. A total of 132 units were affected. The recalled lot numbers are: 7432470, 7434917, 7434918, and 7438322.

The affected devices were distributed with incorrect product descriptions on both the internal and external labels. The product description discrepancy may create potential for confusion regarding device specifications and properties.

The affected devices were distributed across the United States in the following states: Florida, North Carolina, Massachusetts, Minnesota, Ohio, Washington D.C., Virginia, California, Wisconsin, Nebraska, Texas, New York, Michigan, Oregon, New Jersey, South Carolina, Arizona, Utah, Rhode Island, Indiana, Georgia, and Colorado. International distribution also occurred in Canada, Australia, New Zealand, Cyprus, Sweden, Finland, Slovenia, and Great Britain.

Healthcare providers and facilities that have received devices from the affected lot numbers should verify their device labeling and contact Integra LifeSciences Corp. for further information and guidance.

The recalled product

Product
CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810 Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.
Manufacturer
Integra LifeSciences Corp.
Category
Medical Device — Implantable Shunt
Hazard
Affected units
132

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 (3)

  • UDI-DI: 10381780535874. Lot Numbers: 7432470
  • 7434917
  • 7434918 and 7438322.

Distribution

Distributed nationwide across the United States.

The notice also names 22 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Integra LifeSciences Corp. 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 3 products in this recall →

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