CODMAN CERTAS® Plus 828805PLRecalls & reported problems
Integra LifeSciences Switzerland Sàrl · CODMAN CERTAS® Plus Programable Valve Inline Valve with SIPHONGUARD® and Accessories Includes: Ventricular Catheter, Seperable Distal Catheter, Priming Adapter, Right Angle Adapter and Information Manual · Class 2 · Implant
All models of CODMAN CERTAS Plus (14)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10381780521211), received between Oct 28, 2022 and Nov 22, 2024 — classified as 4 injuries.
The most frequently reported specific device problem is “Break” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Improper Flow or Infusion1
- Infusion or Flow Problem1
- Obstruction of Flow1
Patient problems
- Headache2
- Hematoma2
- Cerebral Ventriculomegaly1
- Failure of Implant1
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryNov 22, 2024Break; Break
A FACILITY REPORTED A CERTAS VALVE (ID 828805PL) WAS IMPLANTED ON (B)(6) 2024. THE VALVE WAS BROKEN, THEREFORE, IT WAS REMOVED AND REPLACED WITH A COMPETITOR'S VALVE ON (B)(6), 2024. DURING THE REVISION, THE TEAM FOUND THE VALVE WAS PHYSICALLY BROKEN AT ITS DISTAL END. ALL THE BROKEN PARTS WERE REMOVED.
Patient problems: Insufficient Information
MAUDE report 20757330 ↗InjuryJan 25, 2023Obstruction of Flow; Obstruction of Flow
InjuryNov 28, 2022Infusion or Flow Problem; Infusion or Flow Problem
(MW5112968) "CODMAN CERTAS PLUS PROGRAMMABLE VALVE WITH INLINE SIPHONGUARD MALFUNCTIONED. PROGRAMMED UP TO 6 BUT STILL CAUSING PATIENT TO OVER DRAIN. PATIENTS CONDITION DECLINED RESULTING IN HEADACHES AND A HEMATOMA REQUIRING SURGERY TO REMOVE THE DEVICE." IMPLANT DATE - (B)(6) 2022. EXPLANT DATE - (B)(6) 2022. ACCORDING TO ADDITIONAL INFORMATION RECEIVED, IT IS UNKNOWN IF THE VALVE WAS REPLACED. THE PATIENT IS IMPROVING.
Patient problems: Headache; Hematoma
MAUDE report 15873301 ↗InjuryOct 28, 2022Improper Flow or Infusion
CODMAN CERTAS PLUS PROGRAMMABLE VALVE WITH INLINE SIPHONGUARD MALFUNCTIONED. PROGRAMMED UP TO 6 BUT STILL CAUSING PATIENT TO OVER DRAIN. PATIENTS CONDITION DECLINED RESULTING IN HEADACHES AND A HEMATOMA REQUIRING SURGERY TO REMOVE THE DEVICE. FDA SAFETY REPORT ID # (B)(4).
Patient problems: Failure of Implant; Headache; Hematoma
MAUDE report 15699318 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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