CODMAN CERTAS 82-8811PLRecalls & reported problems
Medos International Sàrl · CODMAN CERTAS Plus Programmable Valve Inline Small Valve with Accessories Includes: Ventricular Catheter, Separable Distal Catheter, Priming Adapter, Right Angle Adapter and Information Manual · Class 2 · Implant
All models of CODMAN CERTAS (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886704081906), received between Dec 28, 2022 and Oct 10, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Failure to Align” (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 Align1
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 10, 2025Failure to Align; Failure to Align
InjuryDec 28, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
A FACILITY REPORTED A CERTAS VALVE (ID 828811PL) WAS IMPLANTED ON (B)(6) 2022 WITH A SET PRESSURE OF 7. ON (B)(6) 2022, VALVE WAS FOUND TO BE INCORRECTLY SET TO 3. THE PATIENT HAD SYMPTOMS OF OVER-DRAINAGE. A 3T MRI WAS PERFORMED ON (B)(6) 2022 PRIOR ON FINDING THE INCORRECT SETTING. THE VALVE WAS REMOVED ON (B)(6) 2022.
Patient problems: Insufficient Information
MAUDE report 16064203 ↗
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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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