CODMAN® CERTAS® 828814PLRecalls & reported problems
Integra LifeSciences Switzerland Sàrl · CODMAN® CERTAS® Plus Programmable Valve Inline Small Valve Only with SIPHONGUARD® · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10381780535942), received between Jul 25, 2025 and May 15, 2026 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (2 reports).
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
- Break2
- Failure to Align1
- Unintended System Motion1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Headache1
- Insufficient Information1
- Sleep Dysfunction1
- Vomiting1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryMay 15, 2026Unintended System Motion
MalfunctionJan 12, 2026Break
InjuryDec 30, 2025Failure to Align; Failure to Align
A FACILITY REPORTED A CERTAS VALVE (ID 828814PL) SETTING WOULD NOT CHANGE. NO PATIENT INJURY REPORTED, HOWEVER, ACCORDING TO INFORMATION PROVIDED, REVISION/MEDICAL INTERVENTION REQUIRED, IT IS UNKNOWN WHAT TYPE OF INTERVENTION. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER SEVERAL ATTEMPTS.
Patient problems: Insufficient Information
MAUDE report 23931349 ↗InjuryJul 25, 2025Break; Break
A FACILITY REPORTED A CERTAS VALVE (ID 828814PL) WAS IMPLANTED ON (B)(6) 2025. AFTER A WEEK, THE PATIENT RETURNED FOR A CHECK-UP WITH SYMPTOMS OF HEADACHE, IRRITABILITY, INABILITY TO SLEEP, AND VOMITING. IT WAS OBSERVED THAT THE VALVE APPEARED TO BE BROKEN IN THE PATIENT¿S CRANIAL AREA. THEREFORE, THE VALVE WAS REMOVED AND REPLACED ON (B)(6) 2025. THE PATIENT DID NOT EXPERIENCE A FALL OR ANY HEAD TRAUMA. THE PATIENT WAS DOING WELL AT THE TIME OF DISCHARGE. ADDITIONAL INFORMATION: "THE VALVE ANTISIPHON DEVICE SNAPPED IN THE PATIENT WHICH IS WHAT CAUSED IT TO BE EXPLANTED. NOTHING WRONG WITH THE BACTISEAL CATHETER."
Patient problems: Headache; Sleep Dysfunction; Vomiting
MAUDE report 22608550 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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