proGAV® FV424TRecalls & reported problems
Christoph Miethke GmbH & Co. KG · PROGAV SYSTEM W/SPRUNG RESERVOIR · Class 2 · Implant
All models of proGAV (28)
Data updated Oct 18, 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 04041906132217), received between May 13, 2021 and Apr 5, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Infusion or Flow 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 18, 2026.
Most reported problems
Device problems
- Infusion or Flow Problem2
- 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 5, 2022Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PROGAV (PART # FV424T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN 2007. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN UNDERDRAINAGE AND DIFFICULT TO ADJUST. THE PATIENT UNDERWENT A REVISION PROCEDURE 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: (B)(6). HEIGHT: 180 CENTIMETERS (CM). WEIGHT: (B)(6). GENDER: MALE.
Patient problems: Hydrocephalus
MAUDE report 14017421 ↗InjuryMay 13, 2021Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem
IT WAS REPORTED TO MIETHKE THAT A PROGAV SHUNTSYSTEM (PART # FV424T) AND A PROSA VALVE (PART # FV701T) (REF. MDR ID 3004721439-2021-00121) WERE IMPLANTED DURING A PROCEDURE PERFORMED IN 2010. ACCORDING TO THE COMPLAINANT, THE SHUNTSYSTEM WAS BELIEVED TO BE OPERATING IN UNDER-DRAINAGE AND AN ADJUSTMENT PROBLEM OCCURRED. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2021. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: (B)(6) YEARS. WEIGHT: (B)(6) KILOGRAMS (KG). HEIGHT: 155 CENTIMETERS (CM). GENDER: MALE. THE SAME EVENT: MEDWATCH # 3004721439-2021-00121.
Patient problems: Hydrocephalus
MAUDE report 11816046 ↗
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- proGAV 2.0® FX410TChristoph Miethke GmbH & Co. KG · Shunt, central nervous system and components119 reports
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- PROGAV 2.0 FX643TAesculap AG · Shunt, central nervous system and components100 reports
- M.BLUE PLUS FX804TAesculap AG · Shunt, central nervous system and components82 reports
- proSA® FV701TChristoph Miethke GmbH & Co. KG · 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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