proGAV® FV431TRecalls & reported problems
Christoph Miethke GmbH & Co. KG · PROGAV SYSTEM W/CONTROL RESERVOIR · Class 2 · Implant
All models of proGAV (28)
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 04041906132439), received between Jun 22, 2018 and Sep 21, 2021 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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
- Device Operates Differently Than Expected1
- Mechanical Problem1
- Use of Device Problem1
Patient problems
- Hydrocephalus1
- No Code Available1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 21, 2021Mechanical Problem; Mechanical Problem
IT WAS REPORTED MIETHKE THAT A PROGAV SYSTEM W/CONTROL RESERVOIR (PART # FV431T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, THE VALVE WAS ORIGINALLY IMPLANTED AND PROGRAMMED TO 6 MMHG WITHOUT COMPLICATION. ON (B)(6) 2016, THE VALVE WAS FOUND TO NOT BE PROGRAMMED. THE PATIENT WAS REFERRED TO THE HOSPITAL WHERE AN IMAGING EXAM WAS PERFORMED, WHICH CONFIRMED THE VALVE LOCATION. ADDITIONAL ATTEMPTS TO PROGRAM THE VALVE WERE PERFORMED, BUT WERE UNSUCCESSFUL. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2016. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: (B)(6), WEIGHT: (B)(6), HEIGHT: (B)(6), GENDER: UNKNOWN.
Patient problems: Hydrocephalus
MAUDE report 12510324 ↗MalfunctionJun 22, 2018Use of Device Problem; Device Operates Differently Than Expected
PATIENT RECEIVED A VENTRICULOPERITONEAL SHUNT LAST YEAR. HE CAME BACK TO THE HOSPITAL WITH AMS AND CT SCAN SHOWED LARGER VENTRICLES. WE TAPPED THE SHUNT WITH NO INFECTION. WANTED TO CHANGE THE VALVE SETTING OF THE PROGRAMMABLE PROGAV VALVE TO A LOWER SETTING TO IMPROVE THE DRAINAGE, HOWEVER, WE COULD NOT CHANGE THE SETTING. PATIENT NEEDED TO BE TAKEN TO THE OR TO CHANGE THE VALVE.
Patient problems: No Code Available
MAUDE report 7629460 ↗
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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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