GAV® FV332TRecalls & reported problems
Christoph Miethke GmbH & Co. KG · GAV SYSTEM W.PRECHAMBER 10/40 · Class 2 · Implant
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 04041906127206), received between Dec 17, 2021 and Feb 7, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Mechanical 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
- Mechanical Problem2
- Adverse Event Without Identified Device or Use Problem1
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.
MalfunctionFeb 7, 2024Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PROGAV SYSTEM (#FV332T) WAS IMPLANTED DURING A PROCEDURE PERFORMED 2015. ACCORDING TO THE COMPLAINANT, THE VALVE SHOWED PROBLEMS, THE PATIENT DOES NOT FEEL WELL. THE SHUNTSSYSTEM IST STILL IMPLANTED. GENDER: MALE.
Patient problems: Hydrocephalus
MAUDE report 18657888 ↗InjuryDec 17, 2021Mechanical Problem; Mechanical Problem
ACCORDING TO THE COMPLAINANT A GAV SYSTEM WAS BLOCKED POSTOPERATIVELY. THE VALVE WAS IMPLANTED ON AN UNSPECIFIED DATE. IT WAS REVISED ON (B)(6) 2017 AND WAS RETURNED TO THE MANUFACTURER. FURTHER DETAILS WERE NOT PROVIDED.
Patient problems: Hydrocephalus
MAUDE report 13029031 ↗
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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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