proGAV 2.0® FX449TRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04041906137755), received between Sep 16, 2021 and Apr 25, 2024 — classified as 3 injuries.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 25, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A SHUNTASSISTANT (#FX449T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN (B)(6) 2019.ACCORDING TO THE COMPLAINANT, THE VALVE 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: 20 YEARS. WEIGHT: 50 KGS.HEIGHT: 165 CM.GENDER: MALE.SAME EVENT AS # 3004721439-2024-00112.

  Patient problems: Hydrocephalus

  MAUDE report 19180030 ↗
• InjuryJan 11, 2024Mechanical Problem; Mechanical Problem

  IT HAS BEEN REPORTED THAT A PROGAV SHUNT SYSTEM (#FX449T) WAS UNABLE TO ADJUST THE PRESSURE OF THE VALVE DURING IMPLANTATION. THIS OCCURRED DURING SURGERY ON AN 8-MONTH-OLD INFANT. AFTER IMPLANTATION, THE VALVE SHOULD BE NORMALLY ADJUSTABLE, BUT IT WAS UNABLE TO CHANGE THE HIGH FLOW RATE. THIS IS EXTREMELY RARE - THE VALVE WAS REPLACED WITH ANOTHER OF THE SAME TYPE. THE HOSPITAL DEPARTMENT HAD TO GET A NEW VALVE FROM THE OR'S STOCK AND REPLACE IT. THIS AFFECTED THE OPERATION TIME, WHICH WAS EXTENDED BY 5 MINUTES. FOR THE PATIENT, THIS MEANT AN EXTENSION OF THE OPERATION TIME, WHICH LED TO AN INCREASED RISK.

  Patient problems: Hydrocephalus

  MAUDE report 18498168 ↗
• InjurySep 16, 2021Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (PART # FX449T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN 2019. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE BLOCKED AND WAS DIFFICULT TO ADJUST. 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: 100 CENTIMETERS (CM). WEIGHT: (B)(6). GENDER: UNKNOWN.

  Patient problems: Hydrocephalus

  MAUDE report 12484744 ↗