CODMAN CERTAS® Plus 828824PLRecalls & reported problems
Integra LifeSciences Switzerland Sàrl · CODMAN CERTAS® Plus Programmable Valve Right Angle Valve Only with SIPHONGUARD®, Includes: Priming 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10381780529491), received between Jun 22, 2023 and Sep 12, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Failure to Read Input Signal” (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
- Failure to Read Input Signal1
- Insufficient Device Problem Information1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 12, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
A FACILITY REPORTED A CERTAS VALVE (ID 828824PL) WITH A DEFECTIVE ANTI-SIPHON MECHANISM. THE DISTAL END AND VENTRICULAR CATHETER WERE PATENT. VALVE DIDN¿T HAVE ANY OBVIOUS PLUG OR CLOT. INITIALLY, SURGEON ASSUMED THAT THE PATIENT NEEDED LOW PRESSURE BUT THE VALVE WAS SET TO PERFORMANCE LEVEL 1. THE VALVE WAS PUMPED NUMEROUS TIMES AND POSITIONED THE PATIENT UPRIGHT. THERE WAS SUSPICION OF DEFECTIVE ANTI-SIPHON MECHANISM, THEREFORE, THE VALVE WAS EXPLANTED.
Patient problems: Insufficient Information
MAUDE report 23037664 ↗MalfunctionJun 22, 2023Failure to Read Input Signal; Failure to Read Input Signal
MEDWATCH REPORT #: 5201770000-2023-8076 A FACILITY REPORTED THAT A PHYSICIAN WAS UNABLE TO PROGRAM THE CERTAS VALVE (ID (B)(6)). THE EVENT HAPPENED DURING SET UP FOR SURGICAL PROCEDURE, THE PATIENT WAS NOT IN THE OPERATING ROOM YET. THE PHYSICIAN GRABBED THE SECOND PROGRAMMER USING THE SAME VALVE, BUT WAS STILL UNABLE TO PROGRAM. THEREFORE, THE PHYSICIAN GRABBED A NEW VALVE AND WAS ABLE TO GET IT TO PROGRAM PROPERLY. THE FIRST VALVE WAS BELIEVED TO BE DEFECTIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17182972 ↗
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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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