CODMAN® CERTAS® Plus 828817PLRecalls & reported problems
Integra LifeSciences Switzerland Sàrl · CODMAN® CERTAS® Plus Programmable Valve Inline Small Valve with SIPHONGUARD®, Accessories and Unitised BACTISEAL® Catheter Includes: BACTISEAL Ventricular Catheter, BACTISEAL Unitized Distal Catheter, Priming Adapter, Right Angle Adapter and Information Manual · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 10381780535829), received between Aug 4, 2026 and Aug 4, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Disconnection” (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
- Disconnection1
- Expulsion1
- Unintended System Motion1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 4, 2026Disconnection; Unintended System Motion; Expulsion
A facility reported a Certas valve (ID: 828817PL) changed settings:On (b)(6) 2025, it was programmed to 2. On (b)(6) 2026, the patient underwent an X-ray and presented to the emergency room (ER) with a suspected shunt malfunction. A computed tomography (CT) scan performed the same day revealed a shunt disconnection. The right frontal approach ventricular catheter tip had migrated to the suprasellar cistern in the vicinity of the optic chiasm, and the proximal aspect of the ventricular catheter appeared detached from the shunt valve. The ventricular caliber had slightly increased, particularly in the temporal horns, which may reflect developing hydrocephalus. Also on (b)(6) 2026, the patient underwent magnetic resonance imaging (MRI). Following the MRI, the patient was taken to the operating room (OR) to reattach the catheter to the valve. In the operating room, the Medtronic Strata Programming Tool was erroneously used to reset the shunt to 2.0 (a Medtronic setting, not a Certas Plus setting). However, an X-ray taken on (b)(6) 2026, revealed that the Certas valve was set to 4. The patient was exposed to a 1.5T GE magnet.
Patient problems: Insufficient Information
MAUDE report 50130372 ↗
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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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