PROGAV 2.0 FX609TRecalls & reported problems
Aesculap AG · PROGAV 2.0 SYS SA2.0 20 & PED.CONTR.RES. · Class 2 · Implant
All models of PROGAV 2.0 (43)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04041906503734), received between Mar 24, 2022 and Nov 3, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (2 reports).
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
- Physical Resistance/Sticking2
- Infusion or Flow Problem1
- Insufficient Device Problem Information1
- Obstruction of Flow1
Patient problems
- Hydrocephalus3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 3, 2025Insufficient Device Problem Information; Physical Resistance/Sticking; Insufficient Device Problem Information; Physical Resistance/Sticking
IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX609T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM HAD ADJUSTMENT DIFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE IN (B)(6) 2025. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE COMPLAINED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: Hydrocephalus
MAUDE report 23451560 ↗InjuryNov 3, 2025Obstruction of Flow; Physical Resistance/Sticking; Obstruction of Flow; Physical Resistance/Sticking
THE INVESTIGATION OF THE PRODUCT HAS BEEN COMPLETED.
Patient problems: Hydrocephalus
MAUDE report 23451415 ↗InjuryMar 24, 2022Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (PART # FX609T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE CLOGGED. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022. 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), HEIGHT: 120 CENTIMETERS (CM), WEIGHT: (B)(6), GENDER: UNKNOWN.
Patient problems: Hydrocephalus
MAUDE report 13895734 ↗
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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
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- 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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