CODMAN® CERTAS® 828800PLRecalls & reported problems
Integra LifeSciences Switzerland Sàrl · CODMAN® CERTAS® Plus Programmable Valve Inline Valve Only · Class 2 · Implant
All models of CODMAN CERTAS (8)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10381780535362), received between Aug 21, 2025 and Sep 26, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. 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
- Insufficient Device Problem Information1
- Obstruction of Flow1
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.
MalfunctionSep 26, 2025Obstruction of Flow; Obstruction of Flow
InjuryAug 21, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
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
Other Shunt, central nervous system and components devices
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- Exacta™ 46700Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 recall2 deaths163 reports
- Strata® 42866Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 death160 reports
- proGAV 2.0® FX410TChristoph Miethke GmbH & Co. KG · Shunt, central nervous system and components119 reports
- Becker® 46128Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 recall50 reports
- PROGAV 2.0 FX643TAesculap AG · Shunt, central nervous system and components100 reports
- proSA® FV701TChristoph Miethke GmbH & Co. KG · Shunt, central nervous system and components82 reports
- M.BLUE PLUS FX804TAesculap AG · Shunt, central nervous system and components82 reports
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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