proGAV 2.0® FX462TRecalls & reported problems
Christoph Miethke GmbH & Co. KG · PROGAV 2.0 SYS W/SA20 A.CONTROL RESERV. · 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 04041906137182), received between Sep 30, 2024 and Sep 30, 2024 — 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.
Reports received per month
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.
InjurySep 30, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX462T) WAS IMPLANTED. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM SHOWED ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON (B)(6) 2024. THE COMPLAINANT DEVICE HAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 74 YEARS. WEIGHT: 86 KGS. HEIGHT: 170 CM. GENDER: FEMALE.
Patient problems: Hydrocephalus
MAUDE report 20333586 ↗
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- Strata® 42866Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 death160 reports
- proGAV 2.0® FX410TChristoph Miethke GmbH & Co. KG · Shunt, central nervous system and components119 reports
- Becker® 46128Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 recall50 reports
- PROGAV 2.0 FX643TAesculap AG · Shunt, central nervous system and components100 reports
- proSA® FV701TChristoph Miethke GmbH & Co. KG · Shunt, central nervous system and components82 reports
- M.BLUE PLUS FX804TAesculap AG · Shunt, central nervous system and components82 reports
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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