PROGAV 2.0 FX552TRecalls & reported problems
Aesculap AG · PROGAV 2.0 SYS SA2.0 25 & CONTROL RES. · Class 2 · Implant
All models of PROGAV 2.0 (43)
Data updated Oct 18, 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 04041906503178), received between Mar 16, 2023 and Aug 11, 2025 — classified as 3 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Infusion or Flow Problem2
- 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.
InjuryAug 11, 2025Obstruction of Flow; Infusion or Flow Problem; Obstruction of Flow; Infusion or Flow Problem
IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX552T) WAS IMPLANTED. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVERDRAINAGE AND UNDERDRAINAGE. 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 22772980 ↗InjuryNov 13, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX552T) WAS IMPLANTED. DUE TO THE FACT THAT THE QUESTIONNAIRE WAS NOT COMPLETED, WE ARE UNFORTUNATELY UNABLE TO SAY EXACTLY WHAT THE COMPLAINT WAS REGARDING THE PRODUCT ONLY THE PROGAV 2.0 AND THE CONTROL RESERVOIR WERE SENT IN. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE COMPLAINANT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: Hydrocephalus
MAUDE report 20673560 ↗InjuryMar 16, 2023Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A PROGAV 2.0 (PART # FX552T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE OPERATING IN UNDER-DRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON (B)(6) 2023. THE COMPLAINT DEVICE HAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 60 YEARS. WEIGHT: 86 KILOGRAMS (KG). HEIGHT: 172 CENTIMETERS (CM). GENDER: MALE.
Patient problems: Hydrocephalus
MAUDE report 16553432 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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