proGAV 2.0® FX432TRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04041906137304), received between Sep 21, 2021 and May 20, 2025 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 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.

• InjuryMay 20, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX432T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNSPECIFIED DATE IN 2023. ACCORDING TO THE COMPLAINANT, THE PATIENT'S STATE OF HEALTH DETERIORATED AND THE VALVE WAS REVISED AS A PRECAUTIONARY MEASURE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2025. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE COMPLAINED DEVICE WAS NOT YET RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hydrocephalus

  MAUDE report 22052700 ↗
• InjuryJan 13, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PROGAV 2.0 (#FX432T) WAS IMPLANTED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024. THE COMPLAINED PRODUCT WILL BE RETURNED TO THE MANUFACTURER FOR INVESTIGATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.

  Patient problems: Hydrocephalus

  MAUDE report 21136966 ↗
• MalfunctionSep 16, 2024Inflation Problem; Use of Device Problem; Inflation Problem; Use of Device Problem

  THE PRODUCT WAS RETURNED IN DRY CONDITION TO THE MANUFACTURER FOR EXAMINATION. IT WAS REPORTED THAT THE DEVICE (#FX432T) COULD NOT BE USED DUE TO THE FACHT THAT THE AIR IN THE RESERVOIR COULD NOT BE EXPELLED BY PUMPING. A REPLACEMENT PRODUCT WAS USED AND THE OPERATION WAS COMPLETED. NO COMPLICATIONS WERE REPORTED ON THE PATIENT.

  Patient problems: Hydrocephalus

  MAUDE report 20225094 ↗
• InjurySep 21, 2021Loss of or Failure to Bond; Break; Loss of or Failure to Bond; Break

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX432T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, THE POSTERIOR CATHETER WAS DISCONNECTED. THE PATIENT RETURNED SOMETIME LATER AND COMPLAINED THAT SHE WAS "NOT FEELING RIGHT". A SHUNT SERIES WAS ORDERED AND RESULTS SHOWED THAT THE DISTAL CATHETER WAS FRACTURED. WHEN THE SURGEON EXAMINED THE PATIENT IN THE OPERATING ROOM, THE SHUNT WAS EXPOSED AND THE POSTERIOR CATHETER WAS NOTED TO BE COMPLETELY DISCONNECTED (BELOW THE REINFORCED SECTION DISTAL TO SA). AFTER FINDING THE DISTAL BREAK, THE SYSTEM INCLUDING RESERVOIR, PROGAV, AND SHUNT ASSISTANT WAS EXPLANTED. ANOTHER MIETHKE PRODUCT, FX817T WAS IMPLANTED INSTEAD. 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. NO FURTHER PATIENT INFORMATION ARE AVAILABLE.

  Patient problems: Hydrocephalus

  MAUDE report 12509670 ↗
• InjurySep 21, 2021Loss of or Failure to Bond; Break; Loss of or Failure to Bond; Break

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX432T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, THE POSTERIOR CATHETER WAS DISCONNECTED. THE PATIENT RETURNED SOMETIME LATER AND COMPLAINED THAT SHE WAS "NOT FEELING RIGHT". A SHUNT SERIES WAS ORDERED AND RESULTS SHOWED THAT THE DISTAL CATHETER WAS FRACTURED. WHEN THE SURGEON EXAMINED THE PATIENT IN THE OPERATING ROOM, THE SHUNT WAS EXPOSED AND THE POSTERIOR CATHETER WAS NOTED TO BE COMPLETELY DISCONNECTED (BELOW THE REINFORCED SECTION DISTAL TO SA). AFTER FINDING THE DISTAL BREAK, THE SYSTEM INCLUDING RESERVOIR, PROGAV, AND SHUNT ASSISTANT WAS EXPLANTED. ANOTHER MIETHKE PRODUCT, FX817T WAS IMPLANTED INSTEAD. THE PATIENT UNDERWENT A REVISION PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. NO FURTHER PATIENT INFROMATION ARE AVAILABLE.

  Patient problems: Hydrocephalus

  MAUDE report 12509623 ↗