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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI: 10381780535874. Lot Numbers: 7432470, 7434917, 7434918 and 7438322.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Integra LifeSciences Corp.
- Reason for Recall:
- Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
UDI-DI: 10381780535874. Lot Numbers: 7432470, 7434917, 7434918 and 7438322.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0977-2025
Related Recalls
AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Product Numbers (Catalog Number): (1) ASX15/60 and (2) ASX15/80
Integra LifeSciences
Possibility for the obturator to break (separate).
Potential that the induction seal is not completely sealed to the device tube packaging.
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.