The Recall Desk
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.

What this means for you

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
  • mis-labeling

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.

Related recalls

Same category