CODMAN CERTAS SIPHONGUARD 82-8805PLRecalls & reported problems
Medos International Sàrl · CODMAN CERTAS Plus Programmable Valve Inline Valve with SIPHONGUARD and Accessories Includes: Ventricular Catheter, Separable Distal Catheter, Priming Adapter, Right Angle Adapter and Information Manual · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886704079057), received between May 26, 2022 and May 26, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Material Integrity 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Material Integrity Problem1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 26, 2022Material Separation; Material Integrity Problem; Material Separation; Material Integrity Problem
A PHYSICIAN REPORTED A CERTAS VALVE (828805PL) WAS IMPLANTED IN 2019. THE PATIENT WAS SENT BACK TO THE OPERATING ROOM FOR VALVE EXPLORATION. WHEN THEY OPENED THE INCISION THE VALVE JACKET BURST IN A SPIRAL FASHION. THE DISTAL END THAT WAS ATTACHED TO THE PERITONEAL TUBING SEPARATED AND LOOSE FROM THE VALVE. THE VALVE WAS REMOVED AND REPLACED ON AN UNKNOWN DATE. THERE WAS NO HISTORY OF TRAUMA TO THE AREA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14518806 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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