proGAV® FV435TRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 04041906132477), received between Nov 4, 2020 and Sep 30, 2024 — classified as 14 injuries.

The most frequently reported specific device problem is “Infusion or Flow Problem” (9 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2024Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV (#FX435T) WAS IMPLANTED DURING A PROCEDURE DATE UNKNOWN. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN 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: 21 YEARS, HEIGHT: 175 CM, WEIGHT: 66 KG, GENDER: UNKNOWN.

  Patient problems: Hydrocephalus

  MAUDE report 20333532 ↗
• InjuryApr 4, 2024Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV SHUNT SYSTEM (#FV435T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2008. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM 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: 16 YEARS, 3 MONTHS. WEIGHT: 45 KGS. HEIGHT: 150 CM. GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 19045476 ↗
• InjuryFeb 2, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV SHUNTSYSTEM (#FV435T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED A BLOCKAGE. 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: 63 YEARS, HEIGHT: 176 CENTIMETERS, WEIGHT: 96 KILOGRAMS.

  Patient problems: Hydrocephalus

  MAUDE report 18634468 ↗
• InjuryDec 7, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED TO MIETHKE THAT A PROGAV SYS W/SA 25 A. CONTROL RESERVOIR (PART # FV435T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, THE VALVE WAS NOT ADJUSTABLE AND A BLOCKAGE WAS SUSPECTED. 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: 173 CENTIMETERS (CM), GENDER: UNKNOWN.

  Patient problems: Hydrocephalus

  MAUDE report 12957332 ↗
• InjuryDec 3, 2021Mechanical Problem; Mechanical Problem

  ACCORDING TO THE COMPLAINANT A PROGAV COULD NOT BE ADJUSTED 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 12925850 ↗
• InjuryNov 3, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED MIETHKE THAT A PROGAV SYS W/SA 25 A.CONTROL RESERVOIR (PART # FV435T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2013. 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) KILOGRAMS (KG), HEIGHT: 120 CENTIMETERS (CM), GENDER: UNKNOWN.

  Patient problems: Hydrocephalus

  MAUDE report 12746977 ↗
• InjuryNov 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO MIETHKE THAT A PROGAV SYS W/SA 25 A.CONTROL RESERVOIR (PART # FV435T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE.ACCORDING TO THE COMPLAINANT, A VALVE WAS EXPLANTED AND RETURNED FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT 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.

  Patient problems: Hydrocephalus

  MAUDE report 12746655 ↗
• InjuryNov 3, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO MIETHKE THAT A PROGAV SYS W/SA 25 A. CONTROL RESERVOIR (PART # FV435T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN (B)(6) 2017. ACCORDING TO THE COMPLAINANT, THE VALVE WAS NOT ABLE TO BE ADJUSTED. 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) YEARS, WEIGHT: (B)(6) KILOGRAMS (KG), HEIGHT: 170 CENTIMETERS (CM), GENDER: UNKNOWN.

  Patient problems: Hydrocephalus

  MAUDE report 12746504 ↗
• InjuryOct 13, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FV435T - PROGAV SYS W/SA 25 A. CONTROL RESERVOIR. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE BLOCKED. THE VALVE WAS EXPLANTED AND RETURNED TO THE MANUFACTURER FOR EVALUATION. FURTHER DETAILS WERE NOT PROVIDED.

  Patient problems: Hydrocephalus

  MAUDE report 12625120 ↗
• InjuryOct 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO MIETHKE THAT A PROGAV SYS W/SA 25 A.CONTROL RESERVOIR (PART # FV435T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE PATIENT SUSTAINED A BLOW TO THE HEAD WHICH REQUIRED THAT THE VALVE BE EXPLANTED. THE PATIENT 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.

  Patient problems: Hydrocephalus

  MAUDE report 12586809 ↗
• InjuryApr 30, 2021Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV SHUNTSYSTEM (#FV435T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2018 . ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE OPERATED IN OVER-DRAINAGE AND NOT FURTHER 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: (B)(6) YEARS. WEIGHT: (B)(6) KG. HEIGHT: 158 CM.

  Patient problems: Hydrocephalus

  MAUDE report 11753157 ↗
• InjuryMar 10, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THERE WAS A PROBLEM WITH A PROGAV SHUNTSYSTEM. THE SURGEON SUSPECTED A BLOCKAGE OF THE SHUNTSYSTEM. PATIENT INFORMATIONS: AGE: (B)(6). HEIGHT: (B)(6). WEIGHT: (B)(6). GENDER: UNKNOWN. IMPLANTATION: 2013. EXPLANTATION: (B)(6) 2021.

  Patient problems: Hydrocephalus

  MAUDE report 11454517 ↗
• InjuryNov 5, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THERE WAS A PROBLEM WITH A PROGAV 2.0 SHUNTSYSTEM. THE SURGEON REPORTED THAT 2 YEARS POST OPERATIVE THE PROGAV 2.0 WAS NO LONGER ADJUSTABLE. ADDITIONAL DETAILS OD THE EVENT IS NOT AVAILABLE. PATIENT INFORMATION: AGE Y: (B)(6). HEIGHT CM: 183. WEIGHT KG: (B)(6). IMPLANTATION: 2018. EXPLANTATION: (B)(6) 2020.

  Patient problems: Hydrocephalus

  MAUDE report 10795289 ↗
• InjuryNov 4, 2020Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THERE WAS A PROBLEM WITH A PROGAV VALVE. THE PROGAV ADJUSTED ITSELF AND THE SURGEON SUSPECTED A BLOCKAGE. PATIENT INFORMATION AGE: (B)(6). WEIGHT: (B)(6). HEIGHT: (B)(6). GENDER: UNKNOWN. DATE OF IMPLANTATION: UNKNOWN. DATE OF REMOVAL: (B)(6) 2020.

  Patient problems: Hydrocephalus

  MAUDE report 10785384 ↗