Device 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.
Z-0977-2025
Product summary
- Event
- Event 95951
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 132 units
- Official record key
device-enforcement:Z-0977-2025
Official wording
Reason: Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Code information: UDI-DI: 10381780535874. Lot Numbers: 7432470, 7434917, 7434918 and 7438322.
Distribution pattern: US Nationwide distribution in the states of FL, NC, MA, MN, OH, DC, VA, CA, WI, NE, TX, NY, MI, OR, NJ, SC, AZ, UT, RI, IN, GA, CO and the countries of Canada, Australia, New Zealand, Cyprus, Sweden, Finland, Slovenia and Great Britain.
Derived failure modes
-
Unknown
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.