proGAV 2.0® FX351TRecalls & reported problems
Christoph Miethke GmbH & Co. KG · PROGAV 2.0 WITH SA15 A.SPRUNG RESERVOIR · Class 2 · Implant
All models of proGAV 2.0 (49)
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 04041906140007), received between Aug 27, 2021 and Aug 27, 2021 — classified as 2 injuries.
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.
Most reported problems
Device problems
- Mechanical 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.
InjuryAug 27, 2021Mechanical Problem; Mechanical Problem
ACCORDING TO THE COMPLAINANT A PROGAV WAS VERY DIFFICULT TO REPROGRAM POSTOPERATIVELY. THE PATIENT WAS ORIGINALLY IMPLANTED ON AN UNKNOWN DATE. THE EVENT DATE WAS NOTED AS (B)(6) 2016. THE VALVE WAS EXPLANTED AND RETURNED TO THE MANUFACTURER FOR EVALUATION. THE PATIENT WAS A "COMPLEX HYDROCEPHALUS CHILD". FURTHER DETAILS WERE NOT PROVIDED.
Patient problems: Hydrocephalus
MAUDE report 12377968 ↗InjuryAug 27, 2021Mechanical Problem; Mechanical Problem
ACCORDING TO THE COMPLAINANT A PROGAV HAD A MALFUNCTION POSTOPERATIVELY. THE PATIENT WAS ORIGINALLY IMPLANTED ON AN UNKNOWN DATE. IT WAS REPORTED THAT THE PATIENT WAS "GETTING WORSE" AND THE STAFF TRIED TO UNSUCCESSFULLY ADJUST THE VALVE. THE VALVE WAS EXPLANTED AND RETURNED TO THE MANUFACTURER FOR EVALUATION. FURTHER DETAILS WERE NOT PROVIDED.
Patient problems: Hydrocephalus
MAUDE report 12377905 ↗
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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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