proGAV® FV427TRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04041906132248), received between Aug 6, 2020 and Jan 27, 2025 — classified as 13 injuries.

The most frequently reported specific device problem is “Infusion or Flow Problem” (8 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJan 27, 2025Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV SHUNTSYSTEM (#FV427-T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6)2019. 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 21242467 ↗
• InjuryJun 10, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A PROGAV SHUNTSYSTEM (#FV427T) WAS IMPLANTED DURING A PROCEDURE. 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: 54 YEARS, HEIGHT: 170 CM, WEIGHT: 80 KG, GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 19499992 ↗
• InjuryDec 12, 2023Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV SHUNTSYSTEM (#FV427T) WAS IMPLANTED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN OVERDRAINAGE AND 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: 63 YEARS, HEIGHT: 180 CM, WEIGHT: 90 KG, GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 18313027 ↗
• InjuryNov 2, 2023Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAVSHUNTSYSTEM (#FV427T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2014. 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: 12 YEARS, 8 MONTHS. HEIGHT: 163 CENTIMETERS. WEIGHT: 69 KILOGRAMS. GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 18055769 ↗
• InjurySep 7, 2022Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV SHUNTSYSTEM (PART # FV427T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE DIFFICULT TO ADJUST. THE FLOW CHARACTERISTIC COULD NOT BE CLEARLY DETERMINED. 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: 39 YEARS, 5 MONTHS, HEIGHT: 176 CENTIMETERS (CM), WEIGHT: 99 KILOGRAMS (KG), GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 15374899 ↗
• InjuryOct 21, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED TO MIETHKE THAT A PROGAV SYSTEM W/SA 20 A.SPRUNG RESERVOIR (PART # FV427T) AND A PROSA VALVE (PART # FV701T) (REF. MDR ID 3004721439-2021-00693) WERE IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE PATIENT FELL DOWN AND BUMPED HEAD. THE PHYSICIAN BELIEVED MECHANICAL DAMAGE TO THE PROGAV 2.0 AND THE PROSA VALVE, POSSIBLY OVER-DRAINAGE, OCCURRED AS A RESULT. 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: 165 CENTIMETERS (CM).

  Patient problems: Hydrocephalus

  MAUDE report 12677224 ↗
• InjuryOct 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO MIETHKE THAT A PROGAV SYSTEM W/SA 20 A.SPRUNG RESERVOIR (PART # FV427T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN (B)(6). ACCORDING TO THE COMPLAINANT, THE VALVE WAS BLOCKED. 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 12668829 ↗
• InjuryOct 19, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO MIETHKE THAT A PROGAV SYSTEM W/SA 20 A.SPRUNG RESERVOIR (PART # FV427T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE VALVE PRESSURE WAS NOT ABLE TO BE ADJUSTED. 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. AGE - (B)(6). WEIGHT - (B)(6). HEIGHT - 178.4 CENTIMETERS (CM). GENDER - MALE.

  Patient problems: Hydrocephalus

  MAUDE report 12658489 ↗
• InjuryOct 19, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED TO MIETHKE THAT A PROGAV SYSTEM W/SA 20 A.SPRUNG RESERVOIR (PART # FV427T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, A VALVE BLOCKAGE WAS OBSERVED. 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) (KG). HEIGHT - 100 CENTIMETERS (CM). GENDER - UNKNOWN.

  Patient problems: Hydrocephalus

  MAUDE report 12658486 ↗
• InjuryOct 5, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FV427T - PROGAV SYSTEM W/SA 20 A. SPRUNG RESERVOIR. ACCORDING TO THE COMPLAINANT THE VALVE DYSFUNCTION POSTOPERATIVELY. THE VALVE WAS EXPLANTED AND RETURNED TO THE MANUFACTURER FOR EVALUATION. FURTHER DETAILS WERE NOT PROVIDED.

  Patient problems: Hydrocephalus

  MAUDE report 12579650 ↗
• InjuryOct 5, 2021Mechanical Problem; Mechanical Problem

  ACCORDING TO THE COMPLAINANT A PROGAV WAS BLOCKED POSTOPERATIVELY. THE PATIENT WAS ORIGINALLY IMPLANTED (B)(6) 2013. THE VALVE WAS EXPLANTED AND RETURNED TO THE MANUFACTURER FOR EVALUATION. FURTHER DETAILS WERE NOT PROVIDED. HEIGHT: 175 CM.

  Patient problems: Hydrocephalus

  MAUDE report 12577855 ↗
• InjurySep 9, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV SYSTEM W/SA 20 A.SPRUNG RESERVOIR (#FV427T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN UNDER-DRAINAGE. 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: AGE: (B)(6).

  Patient problems: Hydrocephalus

  MAUDE report 12450661 ↗
• InjuryAug 6, 2020Increase in Pressure; Increase in Pressure

  IT WAS REPORTED THAT A PROGAV SYSTEM AND A PROSA SHUNT (REFERENCE ASSOCIATED MDR ID 3004721439-2020-00153) WERE EXPLANTED FROM A PATIENT ON (B)(6) 2020 DUE TO SUSPECTED UNDERDRAINAGE.

  Patient problems: Hydrocephalus

  MAUDE report 10373892 ↗