PaediGAV® FV303TRecalls & reported problems
Christoph Miethke GmbH & Co. KG · PAEDIGAV SYSTEM W/PRECHAMB.ON VALVE 4/19 · Class 2 · Implant
All models of PaediGAV (15)
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 04041906131180), received between Dec 1, 2023 and Jan 20, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Infusion or Flow Problem” (1 report).
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 Problem1
- Obstruction of Flow1
Patient problems
- Hydrocephalus1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 20, 2026Obstruction of Flow
THE SAMPLES WAS NOW RETURNED TO MANUFACTURER FOR EXAMINATION. ARTICLE # (B)(4) WAS REPORTED IN MEDWATCH 3004721439-2026-00003.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24114711 ↗InjuryDec 1, 2023Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PAEDIGAV (#FV303T) WAS IMPLANTED TOGETHER WITH AN PROGAV 2.0 DURING A PROCEDURE PERFORMED IN (B)(6) 2021. 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: 68 YEARS. GENDER: FEMALE. SAME EVENT/PATIENT AS MEDWATCH#3004721439-2023-00367.
Patient problems: Hydrocephalus
MAUDE report 18249700 ↗
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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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