proGAV® FV441TRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 04041906132545), received between Apr 1, 2021 and Dec 9, 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 16, 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 9, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV SHUNTSYSTEM (#FV441T) WAS IMPLANTED. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE. 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 20877927 ↗
• InjuryAug 11, 2023Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV SHUNTSYSTEM (#FV441T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE SHUNT SHOWED AN UNDER-DRAINAGE, SPONTANEOUS ADJUSTMENT. 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: 9 YEARS. WEIGHT: 24 KILOGRAMS (KG) . HEIGHT: 129 CENTIMETERS (CM). GENDER: MALE

  Patient problems: Hydrocephalus

  MAUDE report 17513640 ↗
• InjuryMay 17, 2023Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  VALVE STRONGLY CONTAMINATES / TISSUE RESIDUES. IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (PART # FX441T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE SHUNT SHOWED AN UNDERDRAINAGE AND ADJUSTMENT DIFFICULTIES 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: 10 YEARS. WEIGHT: 12.4 KILOGRAMS (KG). HEIGHT: 99 CENTIMETERS (CM). GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 16950383 ↗
• InjuryJul 27, 2022Break; Infusion or Flow Problem; Break; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 (#FX410T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022 ACCORDING TO THE COMPLAINANT, THE DISTAL CATHETER RUPTURED SPONTANEOUSLY AT THE NECK HEIGHT. A PART OF THE CATHETER DRIFTED AND GOT STUCK IN THE ABDOMINAL CAVITY. THE PATIENT UNDERWENT A REVISION PROCEDURE. A NEW VALVE WAS PLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 12 YEARS. HEIGHT: 156 CENTIMETERS (CM). WEIGHT: 42 KILOGRAMS (KG). GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 15117004 ↗
• InjuryMay 25, 2022Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV SHUNTSYSTEM (PART # FV441T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2008. 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) 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: 154 CENTIMETERS (CM). WEIGHT: (B)(6). GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 14493143 ↗
• InjuryMar 4, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV SHUNT SYSTEM (PART # FV441T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2009. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE CLOGGED. 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: 120 CENTIMETERS (CM). WEIGHT: (B)(6). GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 13666852 ↗
• InjuryMar 2, 2022Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (PART # FV441T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE BLOCKED AND WAS NOT ABLE TO BE ADJUSTED. 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: 65 CENTIMETERS (CM). WEIGHT: (B)(6).

  Patient problems: Hydrocephalus

  MAUDE report 13655971 ↗
• InjuryFeb 3, 2022Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV SHUNT SYSTEM (PART # FV441T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE BLOCKED 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: (B)(6). WEIGHT: (B)(6). HEIGHT: 61 CENTIMETERS (CM).

  Patient problems: Hydrocephalus

  MAUDE report 13446637 ↗
• 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: 105 CM.

  Patient problems: Hydrocephalus

  MAUDE report 12989581 ↗
• InjuryDec 2, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV SYST.PED.W/SA 20 A.PRECHAMBER. (#FV441T) WAS IMPLANTED 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. HEIGHT: 90CM.

  Patient problems: Hydrocephalus

  MAUDE report 12916739 ↗
• InjuryDec 2, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV SYST.PED.W/SA 20 A.PRECHAMBER. (#FV441T-J) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2017. 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 12916424 ↗
• InjuryNov 30, 2021Mechanical Problem; Mechanical Problem

  ACCORDING TO THE COMPLAINANT A PROGAV WAS NOT ADJUSTABLE POSTOPERATIVELY. THE PATIENT WAS ORIGINALLY IMPLANTED ON AN UNSPECIFIED DATE. THE VALVE WAS EXPLANTED AND RETURNED TO THE MANUFACTURER FOR EVALUATION. FURTHER DETAILS WERE NOT PROVIDED.

  Patient problems: Hydrocephalus

  MAUDE report 12892816 ↗
• InjuryNov 16, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A PROGAV VALVE (PART # FV441T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE VALVE SPONTANEOUSLY ADJUSTED. 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: 130 CENTIMETERS (CM), WEIGHT: (B)(6) KILOGRAMS (KG), GENDER: UNKNOWN.

  Patient problems: Hydrocephalus

  MAUDE report 12823987 ↗
• InjuryNov 3, 2021Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED MIETHKE THAT A PROGAV SYS PED.W/SA 20 A.PRECHAMBER (PART # FV441T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO HAVE A BLOCKAGE AND TO BE OPERATING IN UNDER-DRAINAGE. 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. AGE: (B)(6). WEIGHT: (B)(6). HEIGHT: 55 CENTIMETERS (CM). GENDER: UNKNOWN.

  Patient problems: Hydrocephalus

  MAUDE report 12746545 ↗
• InjuryOct 18, 2021Mechanical Problem; Mechanical Problem

  ACCORDING TO THE COMPLAINANT A PROGAV WAS DIFFICULT TO REPROGRAM POSTOPERATIVELY. THE PATIENT WAS ORIGINALLY IMPLANTED ON (B)(6) 2016. BLOCKAGE WAS ALSO SUSPECTED. TLHE VALVE WAS EXPLANTED ON (B)(6) 2017 AND RETURNED TO THE MANUFACTURER FOR EVALUATION. FURTHER DETAILS WERE NOT PROVIDED. HEIGHT: 67 CM.

  Patient problems: Hydrocephalus

  MAUDE report 12646999 ↗
• InjurySep 24, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV SHUNTSYSTEM (PART # FV441T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN OVERDRAINAGE. REPORTEDLY, FROM AROUND (B)(6) 2021, THE PATIENT COMPLAINED OF A HEADACHE AND VISITED THE HOSPITAL. THE VALVE PRESSURE WAS 17 CENTIMETERS (CM). THE PHYSICIAN SUSPECTED THAT SA WAS NOT FUNCTIONING DUE TO SIGNS OF OVERDRAINAGE WHEN STANDING. ALSO, THE PRESSURE WAS NOT ABLE TO BE CHANGED. 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: 114.2 CENTIMETERS (CM), WEIGHT: (B)(6), GENDER: UNKNOWN.

  Patient problems: Hydrocephalus

  MAUDE report 12529859 ↗
• InjurySep 17, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED MIETHKE THAT A PROGAV SYS PED.W/SA 20 A.PRECHAMBER (PART # FV441T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED 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. AGE: 4.5 MONTHS, WEIGHT: 7 KILOGRAMS (KG), HEIGHT: 61 CENTIMETERS (CM), GENDER: UNKNOWN.

  Patient problems: Hydrocephalus

  MAUDE report 12490118 ↗
• InjurySep 17, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED MIETHKE THAT A PROGAV SYS PED.W/SA 20 A.PRECHAMBER (PART # FV441T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE OPERATING IN OVER-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 12490047 ↗
• InjurySep 3, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED MIETHKE THAT A PROGAV SYS PED.W/SA 20 A.PRECHAMBER (PART # FV441T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, THE VALVE WAS OPERATING IN UNDERDRAINAGE. 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. AGE: (B)(6). WEIGHT: (B)(6). HEIGHT: 60 CENTIMETERS (CM). GENDER: UNKNOWN.

  Patient problems: Hydrocephalus

  MAUDE report 12420956 ↗
• InjuryAug 30, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED MIETHKE THAT A PROGAV SYS PED.W/SA 20 A.PRECHAMBER (PART # FV441T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE VALVE WAS NOT ABLE TO BE ADJUSTED. 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 12385801 ↗
• InjuryAug 27, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV SYSTEM WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, THE PROGAV SYSTEM WAS BELIEVED TO HAVE A BLOCKAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2016. THE COMPLAINANT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. PATIENT INFORMATION: HEIGHT: 68 CM, WEIGHT: (B)(6) KG.

  Patient problems: Hydrocephalus

  MAUDE report 12378542 ↗
• InjuryApr 15, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A PROGAV (PART # FV441T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE DEVICE WAS BELIEVED TO HAVE A DEFECT OF THE BRAKE FUNCTION. 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. PATIENT INFORMATION: AGE: (B)(6). HEIGHT: 140 CENTIMETERS (CM). WEIGHT: (B)(6).

  Patient problems: Hydrocephalus

  MAUDE report 11674970 ↗
• InjuryApr 6, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A PROGAV (PART # FV441T) WAS IMPLANTED ON (B)(6) 2009 . ACCORDING TO THE COMPLAINANT, THE DEVICE WAS BELIEVED TO BE NOT ADJUSTABLE. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE ON (B)(6)2021. PATIENT INFORMATION: AGE Y: (B)(6). HEIGHT CM: 168. WEIGHT KG: (B)(6). GENDER: N/A.

  Patient problems: Hydrocephalus

  MAUDE report 11620008 ↗
• InjuryApr 1, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A PROGAV SHUNTSYSTEM WAS IMPLANTED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, THE DEVICE WAS BELIEVED TO BE ADJUSTMENT PROBLEMS. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE ON (B)(6) 2021. PATIENT INFORMATION: AGE Y:(B)(6). HEIGHT CM: N/A. WEIGHT KG: N/A. GENDER: N/A.

  Patient problems: Hydrocephalus

  MAUDE report 11603119 ↗