proGAV 2.0® FX440TRecalls & reported problems
Christoph Miethke GmbH & Co. KG · PROGAV 2.0 SYS PED.W/SA15 A.PRECHAMBER · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04041906137458), received between Nov 11, 2022 and May 22, 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
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.
MalfunctionMay 22, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX440-T) WAS IMPLANTED. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM LATER SHOWED ADJUSTMENT DIFFICULTIES. THE VALVE IST STILL IMPLANTED AND HAS NOT BEEN REMOVED. NO FURTHER INFORMATION REGARDING THE PRODUCT OR THE PATIENT WAS SUBMITTED.
Patient problems: Hydrocephalus
MAUDE report 19373897 ↗InjuryNov 11, 2022Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT A PROGAV 2.0 (PART # FX440T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN OVERDRAINAGE AND NON-ADJUSTABILITY. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON (B)(6) 2022. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 49 YEARS. HEIGHT: 180 CENTIMETERS (CM). WEIGHT: 80 KILOGRAMS (KG). GENDER: FEMALE. SAME EVENT AS #3004721439-2022-00337.
Patient problems: Hydrocephalus
MAUDE report 15781506 ↗
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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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