PROGAV 2.0 FX574TRecalls & reported problems
Aesculap AG · PROGAV 2.0 SYS SA2.0 10 & SPRUNG RESERV. · Class 2 · Implant
All models of PROGAV 2.0 (43)
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 04041906502508), received between Jun 27, 2025 and Jun 27, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Insufficient Device Problem Information1
- Obstruction of Flow1
- Physical Resistance/Sticking1
Patient problems
- Hydrocephalus1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 27, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO AESCULAP INC. THAT A PROGAV 2.0 SYS SA2.0 10 & SPRUNG RESERV. (PART # FX574T) WAS IMPLANTED ON AN UNSPECIFIED DATE. ACCORDING TO THE COMPLAINANT THE PATIENT WAS NOT DRAINING AND THE VENTRICLES WERE ENLARGED. REPORTEDLY THERE WERE ISSUES PROGRAMMING THE VALVE. THE VALVE MIGHT BE OCCLUDED. THE PATIENT UNDERWENT A REVISION PROCEDURE ON AN UNSPECIFIED DATE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET PROVIDED.
Patient problems: Insufficient Information
MAUDE report 22349865 ↗InjuryJun 27, 2025Obstruction of Flow; Physical Resistance/Sticking; Obstruction of Flow; Physical Resistance/Sticking
IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX574T) WAS IMPLANTED ON AN UNSPECIFIED DATE. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED A MALFUCTION. THE PATIENT UNDERWENT A REVISION PROCEDURE ON AN UNSPECIFIED DATE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE COMPLAINED PRODUCT WAS NOT YET SENT TO THE MANUFACTURER FOR INVESTIGATION.
Patient problems: Hydrocephalus
MAUDE report 22344980 ↗
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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
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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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