CODMAN® CERTAS® 828804PLRecalls & reported problems
Integra LifeSciences Switzerland Sàrl · CODMAN® CERTAS® Plus Programmable Valve Inline Valve Only with SIPHONGUARD® · Class 2 · Implant
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10381780535409), received between Jun 6, 2025 and Dec 11, 2025 — classified as 2 injuries, 3 malfunctions.
The most frequently reported specific device problem is “No Flow” (2 reports).
1 other recall cover devices cleared under the same FDA submission (K223330); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- No Flow2
- Obstruction of Flow2
- Detachment of Device or Device Component1
Patient problems
- Insufficient Information5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryDec 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
A FACILITY REPORTED THE SIPHONGUARD OF A CERTAS VALVE (ID 828804PL) DETACHED IN PATIENT AFTER IMPLANTATION. THEREFORE, THE VALVE WAS REMOVED AND REPLACED.
Patient problems: Insufficient Information
MAUDE report 23782494 ↗MalfunctionOct 31, 2025Obstruction of Flow; Obstruction of Flow
InjurySep 19, 2025Obstruction of Flow; Obstruction of Flow
MalfunctionJun 6, 2025No Flow; No Flow
2 OF 2 REPORTS (SAME FAILURE, DIFFERENT PATIENTS). OTHER MFG REPORT NUMBER: 3013886523-2025-00131. A FACILITY REPORTED THAT AFTER IMPLANTATION OF A CERTAS VALVE AND AFTER CONNECTING THE DISTAL AND PERITONEAL CATHETERS, THE SURGEON WAS UNABLE TO GET A FLOW TO CONFIRM THE FUNCTION OF THE VALVE. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE. NO PATIENT INJURY REPORTED, HOWEVER, AND THE EVENT LED TO 30 MINUTES SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 22159005 ↗MalfunctionJun 6, 2025No Flow; No Flow
1 OF 2 REPORTS (SAME FAILURE, DIFFERENT PATIENTS). OTHER MFG REPORT NUMBER: 3013886523-2025-00132. A FACILITY REPORTED THAT AFTER IMPLANTATION OF A CERTAS VALVE AND AFTER CONNECTING THE DISTAL AND PERITONEAL CATHETERS, THE SURGEON WAS UNABLE TO GET A FLOW TO CONFIRM THE FUNCTION OF THE VALVE. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE. NO PATIENT INJURY REPORTED, HOWEVER, AND THE EVENT LED TO 30 MINUTES SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 22158997 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K223330. One submission often covers many models, so check the product and lot details in each record.
- Z-0978-2025 · Dec 16, 2024 · Open, ClassifiedCODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810PL. Implantable device that provides constant intraventricular pressure and drainage of CSF for
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.