CODMAN® CERTAS® 828811PLRecalls & reported problems
Integra LifeSciences Switzerland Sàrl · CODMAN® CERTAS® Plus Programmable Valve Inline Small Valve with Accessories · 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 10381780535904), received between Jun 6, 2025 and Jun 6, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Output Problem” (1 report).
1 other recall cover devices cleared under the same FDA submission (K223330); they may or may not involve this specific model.
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
- Output Problem1
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.
InjuryJun 6, 2025Output Problem; Output Problem
A PHYSICIAN REPORTED A CERTAS VALVE (ID 828811PL) WAS IMPLANTED ON (B)(6) 2016, WITH A SETTING 4. ON (B)(6) 2017, THE PATIENT SETTING WAS SET TO 5. THE PATIENT HAD MAGNETIC RESONANCE IMAGING (MRI) ON (B)(6) 2023 AND WAS SET AT 5. ON (B)(6) 2025, THE PATIENT HAD A CRANIAL MRI FOR A 2-YEAR FOLLOW-UP. HOWEVER, THE SHUNT WAS MOVED AND SET AT 8. THEY WERE UNABLE TO SET THE VALVE TO 5. THEREFORE, A REPROGRAMMING WAS DONE UNDER FLUOROSCOPY, AND THE SHUNT WAS STILL SET TO 8. DUE TO THE ISSUE, THE VALVE WAS REMOVED AND REPLACED ON (B)(6) 2025. THE PATIENT DID NOT EXPERIENCE ANY SIGNS OR SYMPTOMS DUE TO THE PRODUCT ISSUE. THE PATIENT CONDITION IS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22159991 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K223330. One submission often covers many models, so check the product and lot details in each record.
- Z-0978-2025 · Dec 16, 2024 · Open, ClassifiedCODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810PL. Implantable device that provides constant intraventricular pressure and drainage of CSF for
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.