PaediGAV® FV304TRecalls & reported problems
Christoph Miethke GmbH & Co. KG · PAEDIGAV SYSTEM W/PRECHAMB.ON VALVE 4/24 · Class 2 · Implant
All models of PaediGAV (15)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04041906131197), received between Dec 15, 2022 and Feb 23, 2024 — classified as 4 injuries.
The most frequently reported specific device problem is “Infusion or Flow Problem” (4 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
- Infusion or Flow Problem4
Patient problems
- Hydrocephalus4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryFeb 23, 2024Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PAEDIGAV (#FV304T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022 . ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN UNDERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINANT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 23 MONTHS. HEIGHT: 81.5 CM. WEIGHT: 8.3 KG. GENDER: FEMALE.
Patient problems: Hydrocephalus
MAUDE report 18771807 ↗InjuryApr 6, 2023Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PAEDIGAV (#FV304T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN UNDERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 7 YEARS, 1 MONTH. WEIGHT: 22 KG. GENDER: MALE.
Patient problems: Hydrocephalus
MAUDE report 16694339 ↗InjuryDec 21, 2022Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PAEDIGAV (PART # FV304T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE CLOGGED. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 8 MONTHS, HEIGHT: 70 CENTIMETERS (CM), WEIGHT: 7.9 KILOGRAMS (KG), GENDER: MALE.
Patient problems: Hydrocephalus
MAUDE report 16030221 ↗InjuryDec 15, 2022Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PAEDIGAV (PART # FV304T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE CLOGGED. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 14 MONTHS. HEIGHT: 80 CENTIMETERS (CM). WEIGHT: 18 KILOGRAMS (KG). GENDER: MALE.
Patient problems: Hydrocephalus
MAUDE report 15988931 ↗
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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
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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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