miniNAV® FV667TRecalls & reported problems
Christoph Miethke GmbH & Co. KG · MININAV SET PED.5 W/VENTRICULAR CATHETER · Class 2 · Implant
All models of miniNAV (7)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04041906133153), received between Sep 28, 2026 and Sep 28, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Infusion or Flow Problem” (2 reports).
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
- Infusion or Flow Problem2
Patient problems
- Hydrocephalus2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Infusion or Flow Problem
On(b)(6)2026 MIETHKE received the information about a complaint regarding a miniNAV from C.H.U. de Toulouse.The hospital reported that the implanted valve showed drainage problems. The patient underwent a revision procedure on August 04, 2026. No patient complications were reported as a result of the revision procedure. The device is not available for examination.
Patient problems: Hydrocephalus
MAUDE report 50913373 ↗InjurySep 28, 2026Infusion or Flow Problem
On September 04, 2026 MIETHKE received the information about a complaint regarding a miniNAV from C.H.U. de Toulouse.The hospital reported that the implanted valve caused an over-drainage. The patient underwent a revision procedure on (b)(6) 2026. No patient complications were reported as a result of the revision procedure. The device is not available for examination.
Patient problems: Hydrocephalus
MAUDE report 50913266 ↗
Other Shunt, central nervous system and components devices
- NATUS EDS3 DRAINAGE SYSTEM NT821731CNatus Medical Incorporated · Shunt, Central Nervous System And Components1 recall208 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page