CODMAN CERTAS® Plus 828807PLRecalls & reported problems
Integra LifeSciences Switzerland Sàrl · CODMAN CERTAS® Plus Programable Valve Inline Valve with SIPHONGUARD®, 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 10381780521280), received between Mar 8, 2022 and Feb 27, 2024 — classified as 3 injuries.
The most frequently reported specific device problem is “Device Contamination with Body Fluid” (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
- Device Contamination with Body Fluid1
- Device Difficult to Program or Calibrate1
- Insufficient Flow or Under Infusion1
- Obstruction of Flow1
Patient problems
- Insufficient Information3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryFeb 27, 2024Device Contamination with Body Fluid; Device Contamination with Body Fluid
InjuryJun 27, 2023Obstruction of Flow; Obstruction of Flow
InjuryMar 8, 2022Device Difficult to Program or Calibrate; Insufficient Flow or Under Infusion; Device Difficult to Program or Calibrate; Insufficient Flow or Under Infusion
A FACILITY REPORTED A CERTAS PLUS VALVE WAS IMPLANTED ON (B)(6) 2021. PATIENT DEALT WITH PROGRAMMING ISSUES AS WELL AS UNDERDRAINING. SHUNT WAS EXPLANTED ON (B)(6) 2022 AND REPLACED BY ANOTHER SHUNT.
Patient problems: Insufficient Information
MAUDE report 13695939 ↗
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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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