proGAV 2.0® FX448TRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04041906137748), received between Oct 27, 2020 and Feb 10, 2026 — classified as 12 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2026Obstruction of Flow; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX448T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDER-DRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2025. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE COMPLAINED PRODUCT WAS NOT YET SENT TO THE MANUFACTURER FOR INVESTIGATION.

  Patient problems: Hydrocephalus

  MAUDE report 24303696 ↗
• InjuryJul 1, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX448T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM SHOWED AN 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.

  Patient problems: Hydrocephalus

  MAUDE report 19644389 ↗
• InjuryMay 12, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SUNT SYSTEM (#FX448T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN OVERDRAINAGE. 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: 6 YEARS; HEIGHT: ~120 CENTIMETERS (CM); WEIGHT: ~18 KILOGRAMS (KG); GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 16924432 ↗
• InjuryJun 14, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX448T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN ALTERNATION UNDERDRAINAGE AND 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. WEIGHT: 16 KG. GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 14691348 ↗
• InjuryNov 30, 2021Mechanical Problem; Mechanical Problem

  ACCORDING TO THE COMPLAINANT A PROGAV WAS NOT ADJUSTABLE POSTOPERATIVELY. 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: 69 CM.

  Patient problems: Hydrocephalus

  MAUDE report 12892819 ↗
• InjuryNov 18, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED MIETHKE THAT A PROGAV 2.0 SYS PED.W/SA20 A.BURRHOLE RES (PART # FX448T) 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 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. AGE: (B)(6). WEIGHT: (B)(6). HEIGHT: 120 CENTIMETERS (CM). GENDER: UNKNOWN.

  Patient problems: Hydrocephalus

  MAUDE report 12836435 ↗
• InjuryNov 10, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED MIETHKE THAT A PROGAV 2.0 SYS PED.W/SA20 A.BURRHOLE RES (PART # FX448T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN 2015. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE OPERATING IN UNDER-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: 90 CENTIMETERS (CM), GENDER: UNKNOWN.

  Patient problems: Hydrocephalus

  MAUDE report 12791161 ↗
• InjuryAug 24, 2021Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX448T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATING IN UNDERDRAINAGE AND THE PROGAV 2.0 WAS NOT ABLE TO BE ADJUSTED. 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: (B)(6) CENTIMETERS (CM), WEIGHT: (B)(6) KILOGRAMS (KG), GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 12363173 ↗
• InjuryMay 19, 2021Infusion or Flow Problem; Infusion or Flow Problem

  AGE: 31 YEARS. HEIGHT: 175 CENTIMETERS (CM). WEIGHT: 75 KILOGRAMS (KG). GENDER: UNKNOWN. ADDITIONAL THE PROGAV 2.0 SHUNTSYSTEM WAS BELIEVED TO HAVE A BLOCKAGE.

  Patient problems: Hydrocephalus

  MAUDE report 11849970 ↗
• InjuryFeb 26, 2021Mechanical Problem; Mechanical Problem

  INVESTIGATION IS DONE ON 01/03/2021.

  Patient problems: Hydrocephalus

  MAUDE report 11385777 ↗
• InjuryOct 27, 2020Infusion or Flow Problem; Infusion or Flow Problem

  THE PRODUCT WAS RECEIVED ON 11/06/2020 FOR INVESTIGATION. ONLY THE PROGAV 2.0 VALVE WAS SEND IN. THE INVESTIGATION COULD BE PERFORMED. DATE OF IMPLANTATION: (B)(6) 2018. DATE OF REMOVAL: (B)(6) 2020.

  Patient problems: Hydrocephalus

  MAUDE report 10743694 ↗
• InjuryOct 27, 2020Infusion or Flow Problem; Infusion or Flow Problem

  THE PRODUCT WAS RECEIVED ON 11/06/2020 FOR INVESTIGATION. ONLY THE PROGAV 2.0 VALVE WAS SEND IN. THE INVESTIGATION COULD BE PERFORMED.

  Patient problems: Hydrocephalus

  MAUDE report 10743676 ↗