proGAV® FV421TRecalls & reported problems
Christoph Miethke GmbH & Co. KG · PROGAV W/SHUNTASSIST.25 + DIST.CATH. · Class 2 · Implant
All models of proGAV (28)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04041906132187), received between Sep 13, 2021 and Sep 27, 2024 — classified as 6 injuries.
The most frequently reported specific device problem is “Mechanical Problem” (5 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 Problem5
- Infusion or Flow Problem4
Patient problems
- Hydrocephalus6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjurySep 27, 2024Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PROGAV (#FV421T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE VALVE SHOWED AN OVER-DRAINAGE AND ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON (B)(6) 2024. THE COMPLAINANT DEVICE HAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 15 YEARS, WEIGHT: 33 KGS, HEIGHT: 141 CM. GENDER: MALE SAME EVENT AS # 3004721439-2024-00298.
Patient problems: Hydrocephalus
MAUDE report 20320906 ↗InjuryDec 12, 2023Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem
IMPLANTATION: (B)(6) 2014 EXPLANTATION: (B)(6) 2023 FILE ENTERED WITH LIMITED INFORMATION. DELIVERED IN RETURNKIT IN UNKNOWN LIQUID. AGE Y: 12 / WEIGHT KG: 35 / HEIGHT CM: UNKNOWN / GENDER: FEMALE
Patient problems: Hydrocephalus
MAUDE report 18312027 ↗InjuryJun 22, 2022Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PROGAV SHUNT SYSTEM(#FV421T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN UNDERDRAINAGE AND TO BE NOT ADJUSTABLE. 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: 9 YEARS, HEIGHT: 130 CENTIMETERS (CM), WEIGHT: 41 KILOGRAMS (KG), GENDER: MALE.
Patient problems: Hydrocephalus
MAUDE report 14775437 ↗InjuryDec 16, 2021Mechanical Problem; Mechanical Problem
ACCORDING TO THE COMPLAINANT A PROGAV WAS BLOCKED POSTOPERATIVELY. THE VALVE WAS IMPLANTED ON (B)(6) 2015. IT WAS REMOVED ON (B)(6) 2017 DUE TO THE MALFUNCTION AND RETURNED TO THE MANUFACTURER. FURTHER DETAILS WERE NOT PROVIDED.
Patient problems: Hydrocephalus
MAUDE report 13020725 ↗InjurySep 14, 2021Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PROGAV W/SHUNTASSIST.25 + DIST.CATH. (FV421T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE PROGAV SYSTEM WAS BELIEVED TO BE NOT ADJUSTABLE. 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) YEARS, WEIGHT: (B)(6) KG, HEIGHT: 165 CM.
Patient problems: Hydrocephalus
MAUDE report 12466611 ↗InjurySep 13, 2021Mechanical Problem; Mechanical Problem
IT WAS REPORTED MIETHKE THAT A PROGAV W/SHUNTASSIST.25 + DIST.CATH. (PART # FV421T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE VALVE WAS NOT ABLE TO BE ADJUSTED. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2016. 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). WEIGHT: (B)(6). HEIGHT: (B)(6). GENDER: UNKNOWN.
Patient problems: Hydrocephalus
MAUDE report 12465349 ↗
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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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