PaediGAV® FV272TRecalls & reported problems
Christoph Miethke GmbH & Co. KG · PAEDIGAV WITH DISTAL CATHETER 4/24 · 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04041906114800), received between Jan 5, 2021 and Sep 16, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Calcified” (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.
Most reported problems
Device problems
- Calcified1
- Infusion or Flow Problem1
Patient problems
- Hydrocephalus2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 16, 2022Calcified; Calcified
IT WAS REPORTED THAT A PAEDIGAV (PART # FV272T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, A CALCIFIED CATHETER WAS OBSERVED. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.
Patient problems: Hydrocephalus
MAUDE report 15440815 ↗InjuryJan 5, 2021Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT THERE WAS A PROBLEM WITH A PAEDIGAV VALVE. THE SURGEON SUSPECTED THAT THE VALVE OPERATES IN OVERDRAINAGE AND REPLACED THE VALVE. PATIENT INFORMATION: PATIENT INFORMATION: (B)(6) HEIGHT: 113 CM GENDER:MALE. DATE OF IMPLANTATION: UNKNOWN (2013) DATE OF REMOVAL: (B)(6) 2020.
Patient problems: Hydrocephalus
MAUDE report 11116754 ↗
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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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