proGAV 2.0® FX428TRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04041906136987), received between Jan 13, 2021 and May 16, 2024 — classified as 11 injuries.

The most frequently reported specific device problem is “Infusion or Flow Problem” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMay 16, 2024Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX428T) 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. THE COMPLAINANT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 30 YEARS. HEIGHT: 160 CM. WEIGHT: 65 KG. GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 19335135 ↗
• InjuryMar 26, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX428T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM SHOWED 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: 41 YEARS, 5 MONTHS . WEIGHT: 94 KGS. HEIGHT: 173 CM. GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 18981771 ↗
• InjuryMar 26, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED TO AESCULAP INC. THAT A PROGAV 2.0 SYS SA2.0 25 & SPRUNG RESERV. (PART # FX577T) WAS IMPLANTED APPROXIMATELY 9 YEARS AGO. ACCORDING TO THE COMPLAINANT THE PATIENT UNDERWENT AN ADJUSTMENT. DURING THE ADJUSTMENT, THE PATIENT IMMEDIATELY WAS ADAMANT THAT THE SHUNT FAILED AND WANTED IT REPLACED. REPORTEDLY THE PATIENT WAS EXHIBITING HEADACHE AND NAUSEA AFTER THE ADJUSTMENT. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2024. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4).

  Patient problems: Failure of Implant; Headache; Nausea

  MAUDE report 18981770 ↗
• InjuryJul 26, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A SHUNTASSISTANT (#FV250T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE SHUNT SHOWED AN OVER-DRAINAGE 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: 2 YEARS, 7 MONTHS, WEIGHT: 14 KILOGRAMS (KG), HEIGHT: 93.5 CENTIMETERS (CM), GENDER: MALE. SAME EVENT AS #3004721439-2023-00109.

  Patient problems: Hydrocephalus

  MAUDE report 17401695 ↗
• InjurySep 22, 2022Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (PART # FX428T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE DIFFICULT TO ADJUST AND OPERTED 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: 52 YEARS, HEIGHT: 165 CENTIMETERS (CM), GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 15465136 ↗
• InjuryDec 23, 2021Mechanical Problem; Mechanical Problem

  ACCORDING TO THE COMPLAINANT A PROGAV HAD A DYSFUNCTION POSTOPERATIVELY. THE VALVE WAS IMPLANTED (B)(6) 2017. IT WAS REVISED ON (B)(6) 2017 AND WAS RETURNED TO THE MANUFACTURER. FURTHER DETAILS WERE NOT PROVIDED. HEIGHT: (B)(6).

  Patient problems: Hydrocephalus

  MAUDE report 13078773 ↗
• InjuryNov 12, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM WAS IMPLANTED DURING A PROCEDURE PERFORMED IN ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN OVER-DRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2021. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: (B)(6) YEARS, HEIGHT: UNKNOWN, WEIGHT: UNKNOWN, GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 12804560 ↗
• InjuryAug 30, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED MIETHKE THAT A PROGAV 2.0 SYS W/SA25 A.SPRUNG RESERVOIR (PART # FX428T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, A BLOCKAGE OF THE VALVE WAS SUSPECTED. 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: Insufficient Information

  MAUDE report 12385809 ↗
• InjuryAug 30, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED MIETHKE THAT A PROGAV W/SHUNTASSIST.25 + DIST.CATH. (PART # FX421T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, THE VALVE ADJUSTED ON OWN. 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 12385800 ↗
• InjuryJun 29, 2021Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  ADDITIONAL INFORMATION ARE AVAILABLE: ACCORDING TO THE COMPLAINANT, THE VALVE (PART # FX428T) WAS BELIEVED TO BE OPERATING IN OVERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINANT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. AGE: 42 YEARS. HEIGHT: 163 CM. WEIGHT: 80 KG. SAME EVENT: #MEDWATCH 3004721439-2021-00187.

  Patient problems: Hydrocephalus

  MAUDE report 12088178 ↗
• InjuryJan 13, 2021Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THERE WAS A PROBLEM WITH A PROGAV 2.0 SHUNTSYSTEM. THE SURGEON SUSPECTED AN UNDERDRAINAGE AND ADJUSTMENT ISSUES. PATIENT INFORMATIONS: AGE: (B)(6). HEIGHT: 170 CM. WEIGHT: (B)(6). GENDER: FEMALE. IMPLANTATION: (B)(6) 2018. REMOVAL: (B)(6) 2020.

  Patient problems: Hydrocephalus

  MAUDE report 11164783 ↗