CODMAN CERTAS 82-8802PLRecalls & reported problems
Medos International Sàrl · CODMAN CERTAS Plus Programmable Valve Inline Valve with Accessories and Unitized Catheter Includes: Ventricular Catheter, Unitized Distal Catheter, Priming Adapter, Right Angle Adapter and Information Manual · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886704079026), received between Jul 9, 2021 and Jul 9, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Output Problem” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Output Problem1
Patient problems
- Headache1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 9, 2021Output Problem; Output Problem
A FACILITY REPORTED THAT A PATIENT HAD A CERTAS VALVE IMPLANTED ON (B)(6) 2019 WITH A SETTING OF 4. THE PATIENT HAS A HISTORY OF HEADACHES AND FALLS PRIOR TO THE IMPLANTATION OF THE VALVE THAT GOES TO BACK TO WHEN THE PATIENT WAS A CHILD. THESE HEADACHES AND FALLS DID NOT RESOLVE AFTER THE CERTAS VALVE WAS IMPLANTED. IN (B)(6) 2020 THAT PATIENT HAD AN MRI FOR A CEREBRAL CYST AND HEADACHE. THE PATIENT WENT BACK TO LOS ANGELES AND HAD THEIR SHUNT CHECKED AND THE SETTING WAS AT 1. THE DOCTOR ADJUSTED IT BACK TO 4. IT IS UNKNOWN IF THE SETTING HAD BEEN ADJUSTED BETWEEN 12/2019 AND 10/2020. IN (B)(6) 2020, THE PATIENT HAD SURGERY FOR THE CEREBRAL CYST AND HEADACHE. ON JUNE 25TH, THE PATIENT HAD ANOTHER MRI AND RADIOLOGY REQUESTED THE SHUNT BE CHECKED BEFORE AND AFTER THE MRI TO DETERMINE IF THE VALVE SETTING CHANGED UNINTENTIONALLY OR NOT. IT WAS REPORTED THAT THE VALVE SETTING DID NOT CHANGE.
Patient problems: Headache
MAUDE report 12147571 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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