proGAV® FV411TRecalls & reported problems
Christoph Miethke GmbH & Co. KG · PROGAV WITH SHUNTASSISTANT 10 · Class 2 · Implant
All models of proGAV (28)
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 04041906132088), received between Apr 16, 2024 and Apr 16, 2024 — 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.
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.
InjuryApr 16, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO AESCULAP INC. THAT A PROGAV 2.0 (#FX490T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN 2010. ACCORDING TO THE COMPLAINANT ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM HAS NEVER BEEN ADJUSTED SINCE IT´S INITIAL IMPLANT. WHEN IT WAS TO BE ADJUSTED, IT WAS NOT POSSIBLE TO CHANGE THE VALVES SETTINGS. A REVISION HAS BEEN SCHEDULED FOR (B)(6) 2024. THE COMPLAINANT DEVICE WILL BE RETURNED TO THE MANUFACTURER FOR EVALUATION. AT THE TIME OF THE CREATION OF THIS SUBMISSION, NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4).
Patient problems: Hydrocephalus
MAUDE report 19118526 ↗InjuryApr 16, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT A PROGAV 2.0 (#FX490T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN 2010. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM HAS NEVER BEEN ADJUSTED SINCE IT´S INITIAL IMPLANT. WHEN IT WAS TO BE ADJUSTED, IT WAS NOT POSSIBLE TO CHANGE THE VALVES SETTINGS. A REVISION HAS BEEN SCHEDULED FOR (B)(6) 2024. THE COMPLAINANT DEVICE WILL BE RETURNED TO THE MANUFACTURER FOR EVALUATION. AT THE TIME OF THE CREATION OF THIS SUBMISSION, NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 32 YEARS.
Patient problems: Hydrocephalus
MAUDE report 19114751 ↗
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- Strata® 42866Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 death160 reports
- proGAV 2.0® FX410TChristoph Miethke GmbH & Co. KG · Shunt, central nervous system and components119 reports
- Becker® 46128Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 recall50 reports
- PROGAV 2.0 FX643TAesculap AG · Shunt, central nervous system and components100 reports
- proSA® FV701TChristoph Miethke GmbH & Co. KG · Shunt, central nervous system and components82 reports
- M.BLUE PLUS FX804TAesculap AG · Shunt, central nervous system and components82 reports
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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