proGAV 2.0® FX425TRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04041906136956), received between Jun 8, 2022 and Sep 20, 2023 — classified as 7 injuries.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 20, 2023Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX425T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINANT DEVICE WILL BE RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.

  Patient problems: Hydrocephalus

  MAUDE report 17785031 ↗
• InjuryDec 21, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (PART#: FX425T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN UNDERDRAINAGE. 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.

  Patient problems: Hydrocephalus

  MAUDE report 16028228 ↗
• InjuryAug 25, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SYS W/SA10 A.SPRUNG RESERVOIR (PART # FX425T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE THE VALVE IS BLOCKED. 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. PATIENT DETAILS: AGE - 69 YEARS, WEIGHT - 73.7 KILOGRAMS (KG), HEIGHT - 165 CENTIMETERS (CM), GENDER - UNKNOWN. SAME EVENT AS MEDWATCH-NO: 3004721439-2022-00245; 3004721439-2022-00246; 3004721439-2022-00247

  Patient problems: Hydrocephalus

  MAUDE report 15296747 ↗
• InjuryAug 25, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SYS W/SA10 A.SPRUNG RESERVOIR (PART # FX425T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE THE VALVE IS BLOCKED. 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. PATIENT DETAILS: AGE - 69 YEARS, WEIGHT - 73.7 KILOGRAMS (KG), HEIGHT - 165 CENTIMETERS (CM), GENDER - UNKNOWN. SAME EVENT AS MEDWATCH-NO.:3004721439-2022-00244; 3004721439-2022-00245; 3004721439-2022-00246.

  Patient problems: Hydrocephalus

  MAUDE report 15296670 ↗
• InjuryAug 25, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SYS W/SA10 A.SPRUNG RESERVOIR (PART # FX425T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE THE VALVE IS BLOCKED. 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. PATIENT DETAILS: AGE - 69 YEARS, WEIGHT - 73.7 KILOGRAMS (KG), HEIGHT - 165 CENTIMETERS (CM), GENDER - UNKNOWN. SAME EVENT AS MEDWATCH-NO.:3004721439-2022-00244; 3004721439-2022-00245; 3004721439-2022-00247.

  Patient problems: Hydrocephalus

  MAUDE report 15296623 ↗
• InjuryAug 25, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SYS W/SA10 A.SPRUNG RESERVOIR (PART # FX425T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE THE VALVE IS BLOCKED. 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. PATIENT DETAILS, AGE - 69 YEARS, WEIGHT - 73.7 KILOGRAMS (KG), HEIGHT - 165 CENTIMETERS (CM), GENDER - UNKNOWN. SAME EVENT AS MEDWATCH-NO.:3004721439-2022-00244; 3004721439-2022-00246; 3004721439-2022-00247.

  Patient problems: Hydrocephalus

  MAUDE report 15296610 ↗
• InjuryJun 8, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV SHUNTSYSTEM (PART # FV446T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE CLOGGED. THE PATIENT UNDERWENT A REVISION PROCEDURE AND GOT A PROGAV 2.0 SHUNTSYSTEM. THE COMPLAINT DEVICE WILL BE RETURN TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 2 YEARS, 7 MONTHS.

  Patient problems: Hydrocephalus

  MAUDE report 14632110 ↗