CODMAN CERTAS® Plus 828803PLRecalls & reported problems
Integra LifeSciences Switzerland Sàrl · CODMAN CERTAS® Plus Programable Valve Inline Valve with Accessories and Unitized BACTISEAL® Catheter Includes: BACTISEAL Ventricular Catheter, BACTISEAL Unitized 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
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10381780521136), received between Nov 2, 2022 and Feb 7, 2024 — classified as 3 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).
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
- Insufficient Device Problem Information3
Patient problems
- Insufficient Information2
- Dizziness1
- Nausea1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryFeb 7, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THIS IS LINKED TO MFG REPORT NUMBERS: 3013886523-2023-00189. 3013886523-2024-00015. A PATIENT REPORTED A CERTAS VALVE WAS IMPLANTED ON (B)(6) 2023. ON (B)(6) 2023, SHUNT WAS SET AT 5. ON (B)(6) 2023, THE SHUNT WAS CHECKED AT 4, AND WAS SET AGAIN TO 5. ON (B)(6) 2023, THE SHUNT WAS CHECKED, AND FOUND AT 4 AGAIN, THEN SET TO 6. ON (B)(6)2023, THE SHUNT WAS CHECKED AND FOUND AT 2, THEREFORE IT WAS SET TO 5 AGAIN. ON (B)(6) 2023, A NEW SHUNT WAS PLACED, AND WAS SET ON 4. THE PATIENT IS CURRENTLY FINE WHEN SITTING OR RESTING. HOWEVER, STILL DIZZY AND NAUSEATED WHEN GETTING UP. THE FIRST SHUNT WAS PLACED ON (B)(6) 2023 WHICH WAS FOUND TO BE DEFECTIVE. THE SECOND SHUNT WAS PLACED ON (B)(6) 2023 AND WAS ALSO DEFECTIVE. THE THIRD SHUNT WAS PLACED ON (B)(6) 2023 WITH SETTING 4. THERE IS CURRENTLY NO COMPLAINT FOR THE THIRD SHUNT. THE PATIENT WAS FINE WHEN SITTING OR RESTING; HOWEVER, SHE EXPERIENCED DIZZINESS AND NAUSEA WHEN GETTING UP.
Patient problems: Dizziness; Nausea
MAUDE report 18664026 ↗InjuryNov 6, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
A FACILITY REPORTED A CERTAS VALVE (ID 828803PL) FAILED WHILE IMPLANTED AND NEEDED TO BE REPLACED. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER SEVERAL ATTEMPTS.
Patient problems: Insufficient Information
MAUDE report 15741420 ↗InjuryNov 2, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
A FACILITY REPORTED A CERTAS VALVE (ID 828803PL) FAILED WHILE IMPLANTED NEEDED TO BE REPLACED. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.
Patient problems: Insufficient Information
MAUDE report 15716638 ↗
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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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