CODMAN® CERTAS® 828810PLRecalls & reported problems
Integra LifeSciences Switzerland Sàrl · CODMAN® CERTAS® Plus Programmable Valve Inline Small Valve Only · Class 2 · Implant
All models of CODMAN CERTAS (8)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10381780535881), received between Dec 30, 2024 and Aug 28, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Failure to Prime” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Dec 16, 2024Open, Classified
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Z-0978-2025 · Root cause: Labeling Change Control · Recall details · FDA record ↗
Most reported problems
Device problems
- Failure to Prime1
- Insufficient Device Problem Information1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 28, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
MalfunctionDec 30, 2024Failure to Prime; Failure to Prime
A FACILITY REPORTED A PHYSICIAN WAS PERFORMING A VENTRICULO-PERITONEAL (VP) SHUNT PLACEMENT. DURING THE PROCEDURE, THE PHYSICIAN BEGAN PRIMING THE CERTAS VALVE PER THE IFU INSTRUCTIONS AND NONE OF THE PRIMING FLUID WAS EXPELLING FROM THE VALVE. NO PATIENT INJURY REPORTED, HOWEVER, THE EVENT LED TO 45 MINUTES SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21042332 ↗
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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 · each recall links to the FDA recall notice
- 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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