proGAV 2.0® FX412TRecalls & reported problems
Christoph Miethke GmbH & Co. KG · PROGAV 2.0 WITH SHUNTASSISTANT 15 · Class 2 · Implant
All models of proGAV 2.0 (49)
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 04041906136543), received between Aug 19, 2022 and Nov 7, 2024 — classified as 1 injury, 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Mechanical Problem1
- Obstruction of Flow1
- Physical Resistance/Sticking1
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.
InjuryNov 7, 2024Obstruction of Flow; Physical Resistance/Sticking; Obstruction of Flow; Physical Resistance/Sticking
IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX412T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE COMPLAINANT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. AGE: 75 YEARS. GENDER: MALE.
Patient problems: Hydrocephalus
MAUDE report 20632372 ↗MalfunctionAug 19, 2022Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (PART # FX412T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6)2022. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED CHANGE THE PRESSURE SETTING DURING A MRI. THIS PRODUCT WAS IMPLANTED IN A PATIENT AT A SET PRESSURE OF 12 CENTIMETERS WATER (CMH2O). AFTER TRANSFER, THE PATIENT SUFFERED FROM ANOTHER DISEASE AND WHEN AN MRI SCAN WAS PERFORMED, IT WAS CONFIRMED THAT THE PRESSURE SETTING HAD BEEN CHANGED TO AROUND 6 CMH2O. THERE IS NO MENTION OF PRESSURE CHANGE IN THE PATIENT'S MEDICAL RECORD, AND THE DOCTOR AT THE FACILITY ALSO STATED THAT NO PRESSURE CHANGE WAS MADE. THE PATIENT WAS UNDER-DRAINAGE AND THE PRESSURE SETTING NEEDED TO BE LOWERED, SO IT DID NOT CAUSE ANY SERIOUS PROBLEMS. THE SHUNTSYSTEM IS STILL IMPLANTED.
Patient problems: Hydrocephalus
MAUDE report 15261254 ↗
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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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