proGAV® FV410TRecalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 04041906132071), received between Apr 15, 2021 and Jan 13, 2025 — classified as 25 injuries.

The most frequently reported specific device problem is “Mechanical Problem” (20 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• InjuryJan 13, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PROGAV (#FV410T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6)2021. ACCORDING TO THE COMPLAINANT, THE VALVE 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 21137098 ↗
• InjurySep 10, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A PROGAV VALVE (#FV410T) WAS IMPLANTED (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE VALVE SHOWED ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON (B)(6) 2024. THE COMPLAINANT DEVICE HAS NOT YET RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.

  Patient problems: Hydrocephalus

  MAUDE report 20179726 ↗
• InjuryAug 22, 2024Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV VALVE (#FV410T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE VALVE SHOWED AN UNDER-DRAINAGE AND ADJUSTMENT DIFFICULTIES. 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: 1 YEARS, 8 MONTHS WEIGHT: 10 KGS HEIGHT: 81 CM GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 20032928 ↗
• InjuryJul 17, 2024Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV VALVE (#FV410T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN 2013. ACCORDING TO THE COMPLAINANT, THE VALVE SHOWED AN UNDER-DRAINAGE AND ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON 06/14/2024. THE COMPLAINANT DEVICE HAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 11 YEARS, 3 MONTHS. WEIGHT: 36 KGS. HEIGHT: 152 CM. GENDER: FEMALE. SAME EVENT AS # 3004721439-2024-00192.

  Patient problems: Hydrocephalus

  MAUDE report 19760264 ↗
• InjuryFeb 23, 2024Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV (#FX410T) WAS IMPLANTED DURING A PROCEDURE PERFORMED. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVERDRAINAGE 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: 10 YEARS. WEIGHT: 10 KG. GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 18771960 ↗
• InjuryJan 10, 2024Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV (#FV410T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) /2022. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN OVERDRAINAGE 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: 19 MONTHS, HEIGHT: 82.4 CM, WEIGHT: 11.1 KG, GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 18489251 ↗
• InjuryDec 1, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A PROGAV (#FV410T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE NOT ADJUSTABLE. 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: 15 MONTHS. HEIGHT: 64 CM. WEIGHT: 7.58 KG. GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 18251071 ↗
• InjuryOct 4, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV (#FV410T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE OPERATED IN OVERDRAINAGE. 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: 10 YEARS, HEIGHT: 132 CENTIMETERS, WEIGHT: 25 KILOGRAMS, GENDER: MALE. SAME PATIENT/EVENT AS MEDWATCH: 3004721439-2023-00290.

  Patient problems: Hydrocephalus

  MAUDE report 17872582 ↗
• InjurySep 12, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV (#FV410T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON UNKNOWN. ACCORDING TO THE COMPLAINANT, THE SHUNT SHOWED A BLOCKAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON (B)(6) 2023. THE COMPLAINANT DEVICE HAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 57 YEARS. WEIGHT: 50 KILOGRAMS. HEIGHT: 155 CENTIMETERS. GENDER: UNKNOWN.

  Patient problems: Hydrocephalus

  MAUDE report 17732163 ↗
• InjuryAug 2, 2023Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV (#FV410T) COMBINED WITH A PROSA (FV701T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON OCTOBER 16, 2012. ACCORDING TO THE COMPLAINANT, THE VALVES CAUSED AN OVERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINT DEVICES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 18 YEARS; HEIGHT: 160 CENTIMETERS (CM); WEIGHT: 56 KILOGRAMS (KG); GENDER: MALE. SAME PATIENT/ EVENT AS MEDWATCH# 3004721439-2023-00230 (PROSA).

  Patient problems: Hydrocephalus

  MAUDE report 17443246 ↗
• InjuryMay 26, 2023Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV (#FV410T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2015. 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: 12 YEARS. WEIGHT: 43 KILOGRAMS (KG) . HEIGHT: 160 CENTIMETERS (CM). GENDER: MALE. SAME EVENT AS #3004721439-2023-00146.

  Patient problems: Hydrocephalus

  MAUDE report 17014614 ↗
• InjuryOct 28, 2022Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV (PART # FV410T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN OVERDRAINAGE AND 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: 5 YEARS. HEIGHT: 104 CENTIMETERS (CM). WEIGHT: 14.5 KILOGRAMS (KG). GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 15692966 ↗
• InjuryAug 30, 2022Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV (PART # FV420T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN OVERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. 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: 10 YEARS. HEIGHT: 130 CENTIMETERS (CM). WEIGHT: 26 KILOGRAMS (KG). GENDER: MALE. SAME EVENT AS MEDWATCH #: 3004721439-2022-00264.

  Patient problems: Hydrocephalus

  MAUDE report 15320753 ↗
• InjuryJul 27, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV (PART # FV410T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE BLOCKED. 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. AGE: 24 YEARS. HEIGHT: 173 CENTIMETERS (CM). WEIGHT: 75 KILOGRAMS (KG). GENDER: UNKNOWN.

  Patient problems: Hydrocephalus

  MAUDE report 15117293 ↗
• InjuryJun 30, 2022Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV (#FV410T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN OVERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. 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: 9 YEARS. HEIGHT: 140 CENTIMETERS (CM). WEIGHT: 45 KILOGRAMS (KG). GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 14881187 ↗
• InjuryMar 24, 2022Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV (PART # FV701T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATING 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: 130 CENTIMETERS (CM), WEIGHT: (B)(6), GENDER: FEMALE. SAME EVENT AS MEDWATCH # 3004721439-2022-00063.

  Patient problems: Hydrocephalus

  MAUDE report 13895559 ↗
• InjuryJan 6, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED TO MIETHKE THAT A PROGAV VALVE (PART # FV410T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, THE VALVE WAS SUSPECTED OF OPERATING IN OVER-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) (KG), HEIGHT: 160 CENTIMETERS (CM), GENDER: UNKNOWN.

  Patient problems: Hydrocephalus

  MAUDE report 13175882 ↗
• InjuryDec 3, 2021Mechanical Problem; Mechanical Problem

  ACCORDING TO THE COMPLAINANT A PROGAV HAD OVERDRAINAGE POSTOPERATIVELY AND COULD NOT BE ADJUSTED. THE VALVE WAS IMPLANTED (B)(6) 2015. IT WAS REMOVED ON (B)(6) 2017 DUE TO THE MALFUNCTION AND RETURNED TO THE MANUFACTURER. FURTHER DETAILS WERE NOT PROVIDED.

  Patient problems: Hydrocephalus

  MAUDE report 12925862 ↗
• InjuryDec 1, 2021Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV VALVE (PART # FV410T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN OVERDRAINAGE AND 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: 156 CENTIMETERS (CM), WEIGHT: (B)(6), GENDER: FEMALE. IT´S THE SAME PATIENT AS MDR ID # 3004721439-2021-00321.

  Patient problems: Hydrocephalus

  MAUDE report 12913391 ↗
• InjuryNov 3, 2021Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED TO MIETHKE THAT A PROGAV VALVE (PART # FV410T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN (B)(6) 2006. ACCORDING TO THE COMPLAINANT, THE VALVE WAS SUSPECTED OF OPERATING IN OVER-DRAINAGE AND ADJUSTED ITSELF. 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. HEIGHT: 120 CENTIMETERS (CM).

  Patient problems: Hydrocephalus

  MAUDE report 12747002 ↗
• InjuryNov 3, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO MIETHKE THAT A PROGAV VALVE (PART # FV410T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, THE VALVE WAS SUSPECTED OF OPERATING IN OVER-DRAINAGE AND A MECHANISM DEFECT WAS OBSERVED. THE PATIENT UNDERWENT A REVISION PROCEDURE ON AN (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 12746508 ↗
• InjuryOct 21, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO MIETHKE THAT A PROGAV VALVE (PART # FV410T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, A FAILURE OF THE ADJUSTMENT MECHANISM OCCURRED; THE VALVE WAS NOT ABLE TO BE ADJUSTED. THE PHYSICIAN UNDERWENT A REVISION PROCEDURE ON AN UNKNOWN DATE. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. HEIGHT: 175 CENTIMETERS (CM).

  Patient problems: Hydrocephalus

  MAUDE report 12677269 ↗
• InjuryAug 6, 2021Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV (PART # FV410T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATING IN UNDER-DRAINAGE 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: 180 CENTIMETERS (CM) WEIGHT: (B)(6) GENDER: MALE SAME EVENT: #MEDWATCH: 3004721439-2021-00220.

  Patient problems: Hydrocephalus

  MAUDE report 12289256 ↗
• InjuryJun 29, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A PROGAV (#FV410T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO HAVE A PROBLEM WITH THE ADJUSTABILITY. 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) HEIGHT: 140 CM WEIGHT: (B)(6) GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 12086499 ↗
• InjuryApr 15, 2021Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  INVESTIGATION IS DONE.

  Patient problems: Hydrocephalus

  MAUDE report 11674761 ↗