PROGAV 2.0 FX577TRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04041906502539), received between Apr 14, 2021 and Aug 25, 2025 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Infusion or Flow Problem” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2025Obstruction of Flow; Physical Resistance/Sticking; Obstruction of Flow; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX577T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (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 22882445 ↗
• MalfunctionAug 22, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT IT WAS IMPOSSIBLE TO CHANGE THE PRESSURE SETTING OF THE PROGAV 2.0 VALVE (#FX577T) BEFORE IMPLANTATION. THE DEVICE WAS RETURNED FOR EXAMINATION TO THE MANUFACTURER.

  Patient problems: Hydrocephalus

  MAUDE report 20030540 ↗
• InjuryFeb 2, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX577T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM SHOWED A BLOCKAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON (B)(6) 2024. THE COMPLAINANT DEVICE HAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 21 YEARS. WEIGHT: 47 KILOGRAMS. HEIGHT: 162 CENTIMETERS. GENDER: UNKNOWN.

  Patient problems: Hydrocephalus

  MAUDE report 18634365 ↗
• InjuryJun 20, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX577T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE SHUNT SHOWED AN 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: 12 YEARS. WEIGHT: 40 KILOGRAMS (KG). HEIGHT: 148 CENTIMETERS (CM). GENDER: UNKNOWN.

  Patient problems: Hydrocephalus

  MAUDE report 17167667 ↗
• InjuryMay 23, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX577T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM SHOWED AN UNDERDRAINAGE. 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: 68 YEARS. WEIGHT: 72 KILOGRAMS (KG). HEIGHT: 168 CENTIMETERS (CM). GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 16989399 ↗
• InjuryDec 9, 2022Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (PART # FX577T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE BLOCKED AND THE INTRAOPERATIVE MEASURED PRESSURE DID NOT CORRESPOND TO THE VALVE SETTING. 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: 40 YEARS. HEIGHT: 180 CENTIMETERS (CM). WEIGHT: 110 KILOGRAMS (KG). GENDER: UNKNOWN.

  Patient problems: Hydrocephalus

  MAUDE report 15953517 ↗
• InjuryNov 4, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (PART # FX577T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN UNDERDRAINAGE. 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: 23 YEARS, HEIGHT: 195 CENTIMETERS (CM), WEIGHT: 95 KILOGRAMS (KG), GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 15730137 ↗
• InjuryMar 3, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (PART # FX577T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN UNDERDRAINAGE. 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: 168 CENTIMETERS (CM). WEIGHT: (B)(6) GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 13663123 ↗
• InjuryMay 19, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SYS SA2.0 25 & SPRUNG RESERV. (PART # FX577T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6), 2021. ACCORDING TO THE COMPLAINANT, THE VALVE ADJUSTMENT WAS NOT POSSIBLE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6), 2021. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. IMPLANTATION: (B)(6) 2021. EXPLANTATION: (B)(6) 2021. AGE: (B)(6) WEIGHT: (B)(6) HEIGHT: 170 CENTIMETERS (CM). GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 11849096 ↗
• InjuryApr 14, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX577T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE CLOGGED /OPERATED IN UNDER-DRAINAGE. THE VENTRICLE SIZE IS NARROWED. 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. PATIENT INFORMATION: AGE: (B)(6) YEARS. HEIGHT: 175 CM. WEIGHT: (B)(6) KG. GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 11664325 ↗