AESCULAP FV298TRecalls & reported problems
Christoph Miethke GmbH & Co. KG · PAEDIGAV SYSTEM W/BURRHOLE RESV.4/24 · Class 2 · Implant
All models of AESCULAP (18)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04041906116330), received between Sep 14, 2021 and Mar 19, 2024 — classified as 3 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Infusion or Flow Problem2
- Mechanical Problem1
Patient problems
- Hydrocephalus3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMar 19, 2024Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PAEDIGAV (#(B)(6)) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN 2019. 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: 6 YEARS, HEIGHT: 108 CM, WEIGHT: 19 KG.
Patient problems: Hydrocephalus
MAUDE report 18928780 ↗InjuryNov 30, 2021Mechanical Problem; Mechanical Problem
ACCORDING TO THE COMPLAINANT A PAEDIGAV WAS BLOCKED POSTOPERATIVELY. THE PATIENT WAS IMPLANTED ON AN UNSPECIFIED DATE. ABOUT 9 YEARS LATER, IT APPEARED TO HAVE BLOCKAGE. THE FLOW WAS SEEN SLIGHTLY BUT ALMOST BLOCKED. THE VALVE WAS EXPLANTED AND RETURNED TO THE MANUFACTURER FOR EVALUATION. FURTHER DETAILS WERE NOT PROVIDED. HEIGHT: 125 CM.
Patient problems: Hydrocephalus
MAUDE report 12892813 ↗InjurySep 14, 2021Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FV298T - PAEDIGAV SYSTEM W/BURRHOLE RESV.4/24. ACCORDING TO THE COMPLAINANT, POST OPERATIVE THE PAEDIGAV SYSTEM HAS TECHNICAL PROBLEMS. ADDITIONAL INFORMATION WAS NOT AVAILABLE.
Patient problems: Hydrocephalus
MAUDE report 12466840 ↗
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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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