PROGAV 2.0 FX661TRecalls & reported problems
Aesculap AG · PROGAV 2.0 W/SA2.0 25 & PED.PRECHAMBER · 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 04041906503802), received between Jun 16, 2021 and Aug 25, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Infusion or Flow Problem” (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.
Most reported problems
Device problems
- Infusion or Flow Problem2
- Mechanical Problem2
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.
InjuryAug 25, 2022Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (PART # FX661T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN UNDERDRAINAGE AND WAS NOT LONGER ADJUSTABLE. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED 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: 2 YEARS. HEIGHT: 80 CENTIMETERS (CM). WEIGHT: 10 KILOGRAMS (KG). GENDER: MALE.
Patient problems: Hydrocephalus
MAUDE report 15297874 ↗InjuryJun 16, 2021Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYTSEM (#FX661T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE OPERATED IN UNDERDRAINAGE AND IS NOT FURTHER- ADJUSTABLE. THE VENTRICULAR CATHETER WAS CLOGGED. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINANT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: (B)(6) HEIGHT: UNKNOWN WEIGHT: (B)(6) GENDER: FEMALE.
Patient problems: Hydrocephalus
MAUDE report 12012578 ↗
Other Shunt, central nervous system and components devices
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- Exacta™ 46700Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 recall2 deaths163 reports
- 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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