PROGAV 2.0 FX641TRecalls & reported problems
Aesculap AG · PROGAV 2.0 WITH SHUNTASSISTANT 2.0 15 · 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 04041906501990), received between Jul 27, 2022 and Sep 10, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Infusion or Flow 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
- Infusion or Flow Problem1
- Obstruction of Flow1
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.
InjurySep 10, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX641T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED A BLOCKAGE THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2025. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE COMPLAINED PRODUCT WAS SENT TO THE MANUFACTURER FOR INVESTIGATION.
Patient problems: Hydrocephalus
MAUDE report 23016626 ↗InjuryJul 27, 2022Infusion or Flow Problem; Infusion or Flow Problem
T WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (PART # FX641T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE OPERATED IN OVERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. NO PATIENT INFORMATION AVAILABLE.
Patient problems: Hydrocephalus
MAUDE report 15117265 ↗
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- 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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