PaediGAV® FV284TRecalls & reported problems
Christoph Miethke GmbH & Co. KG · PAEDIGAV SYSTEM W/PRECHAMBER 4/24 · Class 2 · Implant
All models of PaediGAV (15)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04041906116002), received between Dec 7, 2022 and Jul 20, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Infusion or Flow Problem” (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
- Infusion or Flow Problem1
- Material Rupture1
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.
MalfunctionJul 20, 2023Material Rupture; Material Rupture
NO SAMPLE RETURNED FOR ANALYSIS. THE CASE IS CLOSED WITH THE RECORDING OF THE PRODUCTION DATA.
Patient problems: Hydrocephalus
MAUDE report 17357602 ↗MalfunctionDec 7, 2022Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PAEDIGAV SHUNT SYSTEM (PART # FV284T) WAS FLUSHED BEFORE SURGERY. THE VALVE HAD NO DRAINAGE, EVEN UPON ASPIRATION. NO PATIENT INVOLVEMENT.
Patient problems: Hydrocephalus
MAUDE report 15936530 ↗
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- 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
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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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