proGAV 2.0® FX442TRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04041906137472), received between Apr 22, 2021 and Aug 27, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Mechanical Problem” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX442T) WAS IMPLANTED. 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: 8 YEARS, 1 MONTH. WEIGHT: 34 KG. HEIGHT: 124 CM. GENDER: FEMALE. SAME EVENT AS # 3004721439-2024-00266.

  Patient problems: Hydrocephalus

  MAUDE report 20074699 ↗
• InjurySep 12, 2023Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX442T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN 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: 7 YEARS, 3 MONTHS. HEIGHT: 118 CENTIMETERS. WEIGHT: 16 KILOGRAMS. GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 17732045 ↗
• InjuryNov 16, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (PART # FX442T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. 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: 5 YEARS, 11 MONTHS. HEIGHT: 109 CENTIMETERS (CM). WEIGHT: 17 KILOGRAMS (KG). GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 15810487 ↗
• InjuryNov 4, 2021Mechanical Problem; Mechanical Problem

  ACCORDING TO THE COMPLAINANT A PROGAV HAD A DYSFUNCTION POSTOPERATIVELY; THE ADJUSTMENT WOULD SPONTANEOUSLY CHANGE. THE PATIENT WAS ORIGINALLY IMPLANTED ON (B)(6) 2016. THE VALVE WAS EXPLANTED ON (B)(6) 2017 AND RETURNED TO THE MANUFACTURER FOR EVALUATION. FURTHER DETAILS WERE NOT PROVIDED. HEIGHT: 130 CM.

  Patient problems: Hydrocephalus

  MAUDE report 12752497 ↗
• InjurySep 30, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED MIETHKE THAT A PROGAV 2.0 SYS PED.W/SA25 A.PRECHAMBER (PART # FX442T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE VALVE WAS NOT ADJUSTABLE. 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: 100 CENTIMETERS (CM). GENDER: UNKNOWN.

  Patient problems: Hydrocephalus

  MAUDE report 12558024 ↗
• InjuryJun 2, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX442T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2019. 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. PATIENT INFORMATIONS: AGE: (B)(6) HEIGHT: 120 CM WEIGHT: (B)(6) .

  Patient problems: Hydrocephalus

  MAUDE report 11921908 ↗
• InjuryApr 22, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 (#FX442T) WAS IMPLANTED DURING A PROCEDURE IN 2017. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE BLOCKED. 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. PATIENT INFORMATION: AGE: (B)(6), WEIGHT: (B)(6), GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 11708900 ↗