proGAV® FV425TRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04041906132224), received between Mar 30, 2021 and Feb 2, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Mechanical Problem” (3 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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 2, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PROGAV (#FV425T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN 2019. ACCORDING TO THE COMPLAINANT, THE VALVE SHOWED A MALFUNCTION AND THE PATIENT DESCRIBED CLICKING THAT HE COULD TRIGGER BY MOVING HIS NECK. 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: 36 YEARS. WEIGHT: 100 KGS. HEIGHT: 185 CM. GENDER: UNKNOWN. SAME EVENT AS # 3004721439-2024-00012.

  Patient problems: Hydrocephalus

  MAUDE report 18632119 ↗
• InjuryMay 7, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV SHUNTSYSTEM (PART # FV425T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN SUSPECTED A DRAINAGE ISSUE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON AN UNKNOWN DATE. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.

  Patient problems: Hydrocephalus

  MAUDE report 14323036 ↗
• InjuryApr 19, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A PROGAV SHUNTSYSTEM (PART # FV425T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE NOT ADJUSTABLE. REPORTEDLY, THE PRESSURE WAS ADJUSTED ON (B)(6) 2021. HOWEVER, A FOLLOW-UP ATTEMPT TO ADJUST THE PRESSURE ON (B)(6) 2022 WAS NOT SUCCESSFUL. THE COMPLAINT DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hydrocephalus

  MAUDE report 14140977 ↗
• InjurySep 13, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED MIETHKE THAT A PROGAV SYSTEM W/SA 10 A.SPRUNG RESERVOIR (PART # FV425T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN 2014. ACCORDING TO THE COMPLAINANT, THE VALVE WAS SUSPECTED TO BE OPERATING IN UNDER-DRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2016. 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 12465315 ↗
• InjuryMar 30, 2021Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV SHUNT SYSTEM (PART # FV425T) WAS IMPLANTED. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED OPERATED IN UNDERDRAINAGE AND THE PROGAV WAS DIFFICULT TO ADJUST. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE ON (B)(6) 2021. PATIENT INFORMATIONS: (B)(6), HEIGHT CM: 160, (B)(6). GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 11589657 ↗