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GAV® FV340TRecalls & reported problems

Christoph Miethke GmbH & Co. KG · GAV SYSTEM W/PRECHAMBER ON VALVE 5/30 · Class 2 · Implant

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 04041906131715), received between Sep 23, 2021 and Sep 23, 2021 — classified as 1 injury.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Infusion or Flow Problem1

Patient problems

  • Hydrocephalus1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjurySep 23, 2021Infusion or Flow Problem; Infusion or Flow Problem

    IT WAS REPORTED THAT AGAV SYSTEM W/PRECHAMBER ON VALVE 5/30 (FV340T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE GAV SYSTEM WAS BELIEVED TO BE OVERDRAINAGE. ALSO MENTIONED THAT THE VALVE STOPPED WORKING 3 YEARS AFTER BEING PLACED. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2016. THE COMPLAINANT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. PATIENT INFORMATION: AGE: (B)(6) YEARS, WEIGHT : (B)(6) KG, HEIGHT: 160 CM.

    Patient problems: Hydrocephalus

    MAUDE report 12518454 ↗

Other Shunt, central nervous system and components devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.