proGAV® FV434TRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 04041906132460), received between Jan 20, 2021 and Dec 5, 2024 — classified as 24 injuries.

The most frequently reported specific device problem is “Infusion or Flow Problem” (15 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.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryDec 5, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV SHUNT SYSTEM (#FV434T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024. THE COMPLAINED PRODUCT WAS SENT TO THE MANUFACTURER FOR INVESTIGATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.

  Patient problems: Hydrocephalus

  MAUDE report 20852899 ↗
• InjurySep 3, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX434T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE. 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: 17 YEARS. GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 20125399 ↗
• InjuryNov 2, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A PROGAV SHUNTSYSTEM (#FV434T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM HAD ADJUSTMENT DIFFICULTIES. 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: 16 YEARS. HEIGHT: 161 CENTIMETERS. WEIGHT: 54 KILOGRAMS. GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 18055881 ↗
• InjuryMar 9, 2023Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV SHUNT SYSTEM (#FV434T) WAS IMPLANTED DURING A PROCEDURE ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, THE PROGAV SHOWED AN UNDER-DRAINGE AND ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE 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: (B)(6) WEIGHT: 53.8 KILOGRAMS (KG) HEIGHT: 150 CENTIMETERS (CM) GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 16518446 ↗
• InjuryOct 26, 2022Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV SHUNTSYSTEM (PART # FV434T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN UNDERDRAINAGE AND WAS DIFFICULT TO ADJUST. 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: 9 YEARS AND 2 MONTHS, HEIGHT: 130 CENTIMETERS (CM), WEIGHT: 26 KILOGRAMS (KG), GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 15677118 ↗
• InjuryJun 14, 2022Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV (#FV434T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN UNDERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. 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: 7 YEARS 11 MONTH, HEIGHT: 128 CM, WEIGHT: 27 KG, GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 14691206 ↗
• InjuryApr 29, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV SHUNT SYSTEM (PART # FV434T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATING IN OVERDRAINAGE. 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: 152 CENTIMETERS (CM). WEIGHT: (B)(6) . GENDER: UNKNOWN.

  Patient problems: Hydrocephalus

  MAUDE report 14251818 ↗
• InjuryDec 13, 2021Mechanical Problem; Mechanical Problem

  ACCORDING TO THE COMPLAINANT A PROGAV WAS NOT ADJUSTABLE POSTOPERATIVELY. THE VALVE WAS IMPLANTED ON (B)(6) 2014. THE VALVE WAS EXPLANTED ON (B)(6) 2017 AND RETURNED TO THE MANUFACTURER. FURTHER DETAILS WERE NOT PROVIDED. HEIGHT: 50 CM.

  Patient problems: Hydrocephalus

  MAUDE report 12990288 ↗
• InjuryDec 13, 2021Mechanical Problem; Mechanical Problem

  ACCORDING TO THE COMPLAINANT A PROGAV WAS NOT ADJUSTABLE POSTOPERATIVELY. THE VALVE WAS IMPLANTED ON (B)(6) 2015. THE VALVE WAS EXPLANTED ON (B)(6) 2017 AND RETURNED TO THE MANUFACTURER. FURTHER DETAILS WERE NOT PROVIDED. HEIGHT: 57 CM.

  Patient problems: Hydrocephalus

  MAUDE report 12989557 ↗
• InjuryDec 9, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV SYS W/SA 20 A.CONTROL RESERVOIR (# FV434T) WAS IMPLANTED DURING THE PROCEDURE ON UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE NOT ADJUSTABLE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2017. THE COMPLAINANT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hydrocephalus

  MAUDE report 12968976 ↗
• InjuryDec 8, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED TO MIETHKE THAT A PROGAV SYS W/SA 20 A.CONTROL RESERVOIR (# FV434T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE OVERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2017. THE COMPLAINANT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. FURTHER DETAILS WERE NOT PROVIDED. HEIGHT: 135CM.

  Patient problems: Hydrocephalus

  MAUDE report 12964544 ↗
• InjuryDec 3, 2021Mechanical Problem; Mechanical Problem

  ACCORDING TO THE COMPLAINANT A PROGAV HAD OVERDRAINAGE POSTOPERATIVELY AND COULD NOT BE ADJUSTED. THE VALVE WAS IMPLANTED ON AN UNSPECIFIED DATE IN 2015. IT WAS REMOVED IN 2017 DUE TO THE MALFUNCTION AND RETURNED TO THE MANUFACTURER. FURTHER DETAILS WERE NOT PROVIDED. HEIGHT: 170 CM.

  Patient problems: Hydrocephalus

  MAUDE report 12925710 ↗
• InjuryDec 2, 2021Mechanical Problem; Mechanical Problem

  ACCORDING TO THE COMPLAINANT A PROGAV HAD REDUCED DRAINAGE POSTOPERATIVELY. THE VALVE WAS IMPLANTED ON AN UNSPECIFIED DATE. IT WAS REMOVED DUE TO THE MALFUNCTION AND RETURNED TO THE MANUFACTURER. FURTHER DETAILS WERE NOT PROVIDED.

  Patient problems: Hydrocephalus

  MAUDE report 12920223 ↗
• InjuryDec 1, 2021Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV SHUNTSYSTEM (PART # FV434T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN JANUARY 2012. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN OVERDRAINAGE AND WAS DIFFICULT TO ADJUST. 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. AGE: (B)(6), HEIGHT: 150 CENTIMETERS (CM), WEIGHT: (B)(6) KILOGRAMS (KG), GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 12913758 ↗
• InjuryNov 18, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED TO MIETHKE THAT A PROGAV SYS W/SA 20 A.CONTROL RESERVOIR (PART # FV434T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE VALVE WAS SUSPECTED OF BEING OCCLUDED APPROXIMATELY TWO (2) TO THREE (3) MONTHS POST-IMPLANTATION. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2017. 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 12836857 ↗
• InjuryOct 18, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A PROGAV SHUNTSYSTEM (#FV434T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE PROGAV WAS BELIEVED TO BE BLOCKED. TO CHANGE THE PRESSURE SETTING WAS NOT POSSIBLE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2021. 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).

  Patient problems: Hydrocephalus

  MAUDE report 12651701 ↗
• InjurySep 23, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV SYS W/SA 20 A.CONTROL RESERVOIR. (#FV434T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE NOT ADJUSTABLE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2016. THE COMPLAINANT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. FURTHER DETAILS WERE NOT PROVIDED. PATIENT INFORMATION: AGE: (B)(6).

  Patient problems: Hydrocephalus

  MAUDE report 12519836 ↗
• InjurySep 23, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV SYS W/SA 20 A.CONTROL RESERVOIR. (#FV434T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE NOT ADJUSTABLE 1Y 4M POST OPERATIVELY. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2016. THE COMPLAINANT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. FURTHER DETAILS WERE NOT PROVIDED. PATIENT INFORMATION: AGE: (B)(6) YEARS.

  Patient problems: Hydrocephalus

  MAUDE report 12519831 ↗
• InjurySep 13, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED MIETHKE THAT A PROGAV SYS W/SA 20 A.CONTROL RESERVOIR (PART # FV434T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, THE VALVE WAS OCCLUDED. 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 12465347 ↗
• InjurySep 13, 2021Mechanical Problem; Mechanical Problem

  ACCORDING TO THE COMPLAINANT A PROGAV WAS NOT ADJUSTABLE POSTOPERATIVELY. THE PATIENT WAS ORIGINALLY IMPLANTED IN 2008. THE EXPLANT DATE WAS ON (B)(6) 2016. THE VALVE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. FURTHER DETAILS WERE NOT PROVIDED.

  Patient problems: Hydrocephalus

  MAUDE report 12463632 ↗
• InjurySep 3, 2021Mechanical Problem; Mechanical Problem

  ACCORDING TO THE COMPLAINANT A PROGAV WAS SUSPECTED OF UNDER OR OVER-DRAINAGE POSTOPERATIVELY. THE PATIENT WAS ORIGINALLY IMPLANTED ON (B)(6) 2015. TLHE VALVE WAS EXPLANTED ON (B)(6) 2016 AND RETURNED TO THE MANUFACTURER FOR EVALUATION. FURTHER DETAILS WERE NOT PROVIDED. PATIENT SYMPTOMS DUE TO UNDER-DRAINAGE WERE NOT NOTED. HEIGHT: 150 CM.

  Patient problems: Hydrocephalus

  MAUDE report 12421549 ↗
• InjuryAug 19, 2021Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV SHUNTSYSTEM (PART # FV434T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO HAVE BEEN OPERATING IN OVERDRAINAGE AND HAD A PROBLEM WITH ADJUSTABILITY. 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. AGE: (B)(6). HEIGHT: 143 CENTIMETERS (CM). WEIGHT: (B)(6). GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 12341815 ↗
• InjuryMay 18, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV SHUNTSYSTEM WAS IMPLANTED DURING A PROCEDURE PERFORMED IN (B)(6) 2012. ACCORDING TO THE COMPLAINANT, THE GRAVITATIONAL UNIT WAS BELIEVED TO BE OPERATED IN UNDER-DRAINAGE. 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) WEIGHT: (B)(6) HEIGHT: 180 CM GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 11841495 ↗
• InjuryJan 20, 2021Mechanical Problem; Mechanical Problem

  INVESTIGATION IS COMPLETED THE RESULT WILL BE SUBMITTED WITH THIS FOLLOW UP REPORT.

  Patient problems: Hydrocephalus

  MAUDE report 11202285 ↗