proGAV 2.0® FX427TRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04041906136970), received between Dec 10, 2020 and Feb 22, 2024 — classified as 8 injuries.

The most frequently reported specific device problem is “Mechanical Problem” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 22, 2024Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX427T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM SHOWED AN UNDER-DRAINAGE AND 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: 28 YEARS . WEIGHT: 70 KGS. HEIGHT: 168 CM. GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 18763201 ↗
• InjuryDec 18, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX427T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) /2016. ACCORDING TO THE COMPLAINANT, THE SHUNT SHOWED AN OVER-DRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON (B)(6) 2023. 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 18347352 ↗
• InjuryDec 21, 2022Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (PART # FX427T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATING IN UNDER-DRAINAGE AND WAS NON-ADJUSTABLE. 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. (B)(6). GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 16029215 ↗
• InjuryDec 20, 2021Mechanical Problem; Mechanical Problem

  ACCORDING TO THE COMPLAINANT A PROGAV HAD PRESSURE ADJUSTMENT FAILURE POSTOPERATIVELY. THE VALVE WAS IMPLANTED ON (B)(6) 2017. IT WAS NOTED THAT THE PRESSURE VALUE COULD NOT BE ADJUSTED. IT WAS REVISED ON (B)(6) 2017 AND WAS RETURNED TO THE MANUFACTURER. FURTHER DETAILS WERE NOT PROVIDED.

  Patient problems: Hydrocephalus

  MAUDE report 13047603 ↗
• InjuryDec 7, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH PROGAV 2.0 SYS W/SA20 A.SPRUNG RESERVOIR (#FX427T). ACCORDING TO THE COMPLAINANT, LOOSENESS OF VENTRICULAR CATHETER WAS FOUND. THE PRIMARY SURGERY WAS DONE IN (B)(6) 2017. THE LOOSENESS WAS FOUND BY X-RAY AFTER THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ACCORDING TO THE X-RAY, THE CATHETER WAS COME AWAY APPROXIMATELY 1.5CM FROM THE RESERVER. THE CATHETER WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. FURTHER DETAILS WERE NOT PROVIDED. AGE: (B)(6). WEIGHT: (B)(6). HEIGHT:158CM.

  Patient problems: Hydrocephalus

  MAUDE report 12952838 ↗
• InjuryNov 1, 2021Mechanical Problem; Mechanical Problem

  ACCORDING TO THE COMPLAINANT A PROGAV COULD NOT BE READJUSTED POSTOPERATIVELY. THE PATIENT WAS ORIGINALLY IMPLANTED ON (B)(6) 2016. THE INITIAL PRESSURE VALUE WAS 8 CMH2O. THE VALVE WAS EXPLANTED ON (B)(6) 2017 AND RETURNED TO THE MANUFACTURER FOR EVALUATION. DURING THE REVISION SURGERY, THE SURGEON NOTED DRAINAGE FROM THE VALVE, BUT NOT FROM THE RESERVOIR; BLOCKAGE WAS SUSPECTED. HEIGHT: 170 CM.

  Patient problems: Hydrocephalus

  MAUDE report 12728960 ↗
• InjuryNov 1, 2021Mechanical Problem; Mechanical Problem

  ACCORDING TO THE COMPLAINANT A PROGAV HAD A MALFUNCTION 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: 164 CM.

  Patient problems: Hydrocephalus

  MAUDE report 12728837 ↗
• InjuryDec 10, 2020Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THERE WAS A PROBLEM WITH A PROGAV 2.0 SHUNT SYSTEM. THE SURGEON REPLACED THE SHUNT SYSTEM DUE TO SUSPECTED OVERDRAINAGE AND ADJUSTMENT PROBLEMS. PATIENT INFORMATION: AGE: (B)(6) YEARS OLD; GENDER: FEMALE IMPLANTATION: (B)(6) 2019; REMOVAL: (B)(6) 2020.

  Patient problems: Hydrocephalus

  MAUDE report 10983012 ↗