The Recall Desk
ModerateFDA (Devices)·Z-0979-2025·Announced 2025-01-29

CODMAN CERTAS Plus programmable valve recalled for incorrect label descriptions

Integra LifeSciences is recalling 46 units of the CODMAN CERTAS Plus Programmable Valve due to incorrect product descriptions on internal and external labels. The affected devices were distributed nationwide across the U.S. and internationally.

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 recall involves a labeling error on an FDA Class II medical device with no reported illnesses or injuries. According to FDA severity guidelines, minor labeling errors are classified as Moderate (score 2). The device retains its intended functionality; only the label descriptions are incorrect.

Plain-English summary

The CODMAN CERTAS Plus Programmable Valve Right Angle Valve Only (Model 828820) is an implantable neurosurgical device designed to manage hydrocephalus by providing constant intraventricular pressure monitoring and cerebrospinal fluid drainage. Integra LifeSciences Corp. is recalling 46 units (Lot Number 7415567, UDI-DI: 10381780535997) that were distributed with incorrect product descriptions on both internal and external labels.

The recalled units were distributed nationwide across 22 U.S. 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. Additional distribution occurred in Canada, Australia, New Zealand, Cyprus, Sweden, Finland, Slovenia, and Great Britain.

Healthcare facilities and professionals in receipt of this device should verify that the product description on device labels corresponds to the actual CODMAN CERTAS Plus specifications to ensure proper identification and use. For questions regarding this recall, contact the manufacturer or the FDA.

The recalled product

Product
CODMAN CERTAS Plus Programmable Valve Right Angle Valve Only. Model Number: 828820. Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.
Manufacturer
Integra LifeSciences Corp.
Category
Medical Device
Hazard
  • incorrect-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 (1)

  • UDI-DI: 10381780535997. Lot Number: 7415567.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category