proGAV 2.0® FX426TRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04041906136963), received between Mar 18, 2021 and Dec 21, 2022 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Infusion or Flow Problem” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 21, 2022Fluid/Blood Leak; Infusion or Flow Problem; Fluid/Blood Leak; Infusion or Flow Problem

  ACCORDING TO THE COMPLAINANT, PRIOR TO USE, A LEAK ON THE RESERVOIR SIDE OF THE PROGAV 2.0 SHUNTSYSTEM (PART # FX426T) WAS OBSERVED. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED. AGE: UNKNOWN. WEIGHT: 172 KILOGRAMS (KG). HEIGHT: 80 CENTIMETERS (CM). GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 16028916 ↗
• InjuryDec 6, 2021Obstruction of Flow; Optical Obstruction; Obstruction of Flow; Optical Obstruction

  IT WAS REPORTED THAT A PROGAV 2.0 SYS W/SA15 A.SPRUNG RESERVOIR (PART # FX426T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE RESERVOIR WAS NOTED AS BEING FULL OF STEAM. 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.

  Patient problems: Hydrocephalus

  MAUDE report 12934733 ↗
• InjuryNov 30, 2021Mechanical Problem; Mechanical Problem

  ACCORDING TO THE COMPLAINANT A PROGAV WAS BLOCKED POSTOPERATIVELY. THE PATIENT WAS IMPLANTED ON (B)(6) 2015. ONCE THE PRODUCT WAS IMPLANTED, PRESSURE COULD NOT BE ADJUSTED. HOWEVER, THE PRODUCT WAS REMAINED SINCE THE PATIENT CONDITION WAS GOOD. THE SURGERY FOR BRAIN TUMOR HAD BEEN DONE TWICE SINCE THE PRIMARY SURGERY WITHOUT VALVE FAILURE. HOWEVER THIS TIME, THE REVISION SURGERY WAS NEEDED DUE TO UNDERDRAINAGE. THEREFORE, THE VALVE INVESTIGATION INCLUDED ADJUSTMENT FAILURE WAS REQUESTED. THE VALVE WAS EXPLANTED ON (B)(6) RETURNED TO THE MANUFACTURER FOR EVALUATION. FURTHER DETAILS WERE NOT PROVIDED. HEIGHT: 172 CM.

  Patient problems: Hydrocephalus

  MAUDE report 12892808 ↗
• InjuryAug 19, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (PART #FX426T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO HAVE A BLOCKAGE. 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 12341775 ↗
• InjuryMar 18, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THERE WAS A PROBLEM WITH A SPRUNG RESERVOIR TO THE PROGAV 2.0 SHUNTSYSTEM. ACCORDING TO THE COMPLAINANT,WHEN SHUNT WAS ASSEMBLED ON THE STERILE TABLE THE PHYSICIAN ASSISTANT WAS UNABLE TO PRIME THE SHUNT USING THE CONTROL RESERVOIR. THE PATIENT WAS UNDER ANESTHESIA, THERE WAS NO DELAY IN SURGERY, AND THE SURGEON HAD A BACK-UP SHUNT TO USE INSTEAD. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AS OF THIS REPORT. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE.

  Patient problems: Hydrocephalus

  MAUDE report 11517407 ↗
• InjuryMar 18, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED TO AESCULAP THAT PROGAV 2.0 SYS W/SA15 A.SPRUNG RESERVOIR WAS USED DURING SHUNT PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, WHEN SHUNT WAS ASSEMBLED ON THE STERILE TABLE THE PHYSICIAN ASSISTANT WAS UNABLE TO PRIME THE SHUNT USING THE CONTROL RESERVOIR. FURTHER INFORMATION WAS RECEIVED ON FEBRUARY 24, 2021 WHICH CONFIRMED THAT THE PATIENT WAS UNDER ANESTHESIA, THERE WAS NO DELAY IN SURGERY, AND THE SURGEON HAD A BACK-UP SHUNT TO USE INSTEAD. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AS OF THIS REPORT. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: Hydrocephalus

  MAUDE report 11517229 ↗