FDA Device recall Z-0979-2025
CODMAN CERTAS Plus Programmable Valve Right Angle Valve Only
- FDA Device
- Class II
- ongoing
- Published 2025-01-29
On 2025-01-29 the FDA classified a Class II recall of CODMAN CERTAS Plus Programmable Valve Right Angle Valve Only by Integra Lifesciences, citing potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0979-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-12-16 |
| Published | 2025-01-29 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Integra Lifesciences |
| Distribution | US |
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.
Reason
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Identifiers
| code_info | UDI-DI: 10381780535997. Lot Number: 7415567. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0979-2025%22
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