proGAV 2.0® FX468TRecalls & reported problems
Christoph Miethke GmbH & Co. KG · PROGAV 2.0 SYS PED.W/BURRHOLE RESERVOIR · Class 2 · Implant
All models of proGAV 2.0 (49)
Data updated Oct 16, 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 04041906138134), received between Dec 7, 2021 and Dec 7, 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 16, 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 7, 2021Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH PROGAV 2.0 SYS PED.W/BURRHOLE RESERVOIR (#FX468T). ACCORDING TO THE COMPLAINANT, DURING THE INSERTION OF VP SHUNT PROCEDURE, THE DISTAL END OF THE VENTRICULAR CATHETER INCLUDED WITH THE SET WAS STUCK TO THE STYLET. THE SURGEON IMPLANTED THE CATHETER INTO THE VENTRICLE, BUT, WHEN HE ATTEMPTED TO REMOVE THE STYLET, IT WOULD NOT COME OUT. THE SURGEON REMOVED THE CATHETER, WITH THE STYLET IN SIDE. WITH THE CATHETER REMOVED FROM THE PATIENT, THE DOCTOR TUGGED ON THE STYLET, AND IT CRIMPED THE CATHETER. THE SURGEON SELECTED TO USE ANOTHER VENTRICULAR CATHETER THAN THE ONE THAT WAS PROVIDED WITH THE SET. THERE WAS AN SURGICAL DELAY OF 5-10 MINUTES. THE CATHETER WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: Hydrocephalus
MAUDE report 12953512 ↗
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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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