CODMAN® CERTAS® Plus 828807PLRecalls & reported problems
Integra LifeSciences Switzerland Sàrl · CODMAN CERTAS® Plus Programmable 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
- 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 10381780535430), received between Aug 7, 2026 and Aug 7, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Improper Flow or Infusion” (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.
Reports received per month
Most reported problems
Device problems
- Improper Flow or Infusion1
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.
InjuryAug 7, 2026Improper Flow or Infusion
A sales representative stated:"Patient is a 68-year-old man with normal pressure hydrocephalus. He was shunted in December 2025 and has been having unpredictable responses to valve changes ever since. Patient had subdurals that had to be managed, but not surgically. Recently, his ventricles had collapsed down with small extra axial collections. The physician turned the valve off to 8 and his ventricles remained collapsed with small extra axial collections. He was neurologically doing very well but was having low pressure headaches.""The physician assumed that the valve was defective now that it was set at 8 and the ventricles were not filling up. He felt the valve was probably just staying open and continued to drain. Ultimately, with the postural headaches continuing, the physician really didn't like looking at slit ventricles and small axials so with the hypothesis of the defective valve, the valve being stuck open, despite being set at 8, the physician put him on the schedule to replace what he thought was a defective valve. That was scheduled for next week, but yesterday on (b)(6), he came in with asymptomatic hydro. Images were close to his pre-op scan. The physician reprogram
Patient problems: Headache
MAUDE report 50175253 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.