GAV® FV320TRecalls & reported problems
Christoph Miethke GmbH & Co. KG · GAV W.DISTAL CATH.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 04041906126001), received between Sep 9, 2021 and Dec 13, 2021 — classified as 1 injury, 1 malfunction.
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
- Mechanical 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.
MalfunctionDec 13, 2021Mechanical Problem; Mechanical Problem
ACCORDING TO THE COMPLAINANT A GAV HAD A MALFUNCTION PREOPERATIVELY. THE VALVE WAS TESTED AND FOUND TO BE IMPERMEABLE; THE SURGEON DECIDED TO USE A DIFFERENT VALVE INSTEAD. THE GAV WAS NOT IMPLANTED BUT RETURNED TO THE MANUFACTURER. FURTHER DETAILS WERE NOT PROVIDED.
Patient problems: Hydrocephalus
MAUDE report 12989483 ↗InjurySep 9, 2021Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A GAV W.DISTAL CATH.10/40. (#FV320T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE BLOCKED. 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). WEIGHT: (B)(6). HEIGHT: 163 CM.
Patient problems: Hydrocephalus
MAUDE report 12450704 ↗
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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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