PaediGAV® FV274TRecalls & reported problems
Christoph Miethke GmbH & Co. KG · PAEDIGAV WITH DISTAL CATHETER 9/24 · Class 2 · Implant
All models of PaediGAV (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04041906115005), received between Dec 16, 2021 and Dec 16, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Mechanical 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 18, 2026.
Most reported problems
Device problems
- Mechanical Problem1
Patient problems
- Hydrocephalus1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 16, 2021Mechanical Problem; Mechanical Problem
ACCORDING TO THE COMPLAINANT A PAEDIGAV HAD A MALFUNCTION PREOPERATIVELY. THE VALVE WAS SCHEDULED FOR IMPLANTATION ON (B)(6) 2017; IT WAS TESTED AND FOUND TO BE "DEFECTIVE". IT WAS NOT IMPLANTED AND WAS RETURNED TO THE MANUFACTURER. FURTHER DETAILS WERE NOT PROVIDED.
Patient problems: Hydrocephalus
MAUDE report 13022142 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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