Integra Flow Regulating Valve Low Flow 909512Recalls & reported problems
Integra Neurosciences Implant (France) · The Integra Flow Regulating Valves Low Flow (Standard, Mini) are implantable hydrocephalus valve systems for controlled cerebrospinal fluid (CSF) drainage from the ventricles to the peritoneal cavity or other appropriate drainage site such as the heart’s right atrium. Unlike conventional valves, the Integra Flow Regulating Valve Low Flow is a variable resistance valve that maintains drainage at a constant rate, between 8 and 17 ml/hr, within the physiological range of intracranial pressure. · Class 2 · Implant
Data updated Oct 16, 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 10381780033844), received between Aug 11, 2023 and Aug 11, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Obstruction of Flow” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Obstruction of Flow1
Patient problems
- Headache1
- Hydrocephalus1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 11, 2023Obstruction of Flow; Obstruction of Flow
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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
- 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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