proGAV 2.0® FX419TRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04041906136611), received between Jan 10, 2023 and Aug 11, 2025 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Infusion or Flow Problem” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A PROGAV 2.0 (#FX410T) WAS IMPLANTED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM SHOWED AN INVOLUNTARY VALVE PRESSURE ADJUSTMENT. HERE WAS NO BLOCKAGE, THERE WAS A CLICKING SOUND WHEN THE VALVE WAS PRESSURED AND THE DOCTOR WAS ABLE TO ADJUST THE PRESSURE WITHOUT ANY PROBLEMS. NO REVISON IS SCHEDULED AT THE TIME OF THE REPORT. THE VALVE IS STILL IMPLANTED.

  Patient problems: Hydrocephalus

  MAUDE report 22773391 ↗
• InjuryMar 31, 2025Obstruction of Flow; Physical Resistance/Sticking; Obstruction of Flow; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX419T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE PROGAV 2.0 COULD NOT BE ADJUSTED. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2025. THE COMPLAINED PRODUCT WILL BE SENT TO THE MANUFACTURER FOR INVESTIGATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.

  Patient problems: Hydrocephalus

  MAUDE report 21730153 ↗
• InjuryJan 15, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM(#FX419T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024. THE COMPLAINED PRODUCT WAS NOT YET SENT TO THE MANUFACTURER FOR INVESTIGATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.

  Patient problems: Hydrocephalus

  MAUDE report 21157533 ↗
• InjurySep 18, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV SHUNT SYSTEM (#FX419T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM SHOWED AN UNDER-DRAINAGE. 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: 54 YEARS WEIGHT: 107 KGS HEIGHT: 179 CM GENDER: MALE SAME EVENT AS .

  Patient problems: Hydrocephalus

  MAUDE report 20245596 ↗
• InjuryJan 10, 2023Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (PART # FX419T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN UNDERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED 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: 49 YEARS. HEIGHT: 158 CENTIMETERS (CM). WEIGHT: 71 KILOGRAMS (KG). GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 16134887 ↗