proGAV® FV420TRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04041906132170), received between Sep 28, 2021 and Dec 21, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Mechanical 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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 21, 2022Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV SHUNTSYSTEM (PART # FV420T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN OVERDRAINAGE AND WAS DIFFICULT TO ADJUST. 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. AGE: 10 YEARS, 3 MONTHS, HEIGHT: 144 CENTIMETERS (CM), WEIGHT: 36.5 KILOGRAMS (KG), GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 16029483 ↗
• InjuryDec 22, 2021Mechanical Problem; Mechanical Problem

  ACCORDING TO THE COMPLAINANT A PROGAV WAS OPERATING IN OVER-DRAINAGE AND HAD A DEFECT POSTOPERATIVELY. THE VALVE WAS IMPLANTED (B)(6) 2015. IT WAS REVISED ON (B)(6) 2017 AND WAS RETURNED TO THE MANUFACTURER. FURTHER DETAILS WERE NOT PROVIDED. PATIENT DATA : WEIGHT: (B)(6) AND HEIGHT: 96 CM.

  Patient problems: Hydrocephalus

  MAUDE report 13063031 ↗
• InjuryNov 17, 2021Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED TO MIETHKE THAT A PROGAV W/SHUNTASSIST.20 + DIST.CATH. (PART # FV420T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE VALVE WAS SUSPECTED OF BEING OCCLUDED AND WAS NOT ABLE TO BE ADJUSTED. THE PATIENT UNDERWENT A REVISION PROCEDURE ON AN (B)(6) 2017. 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), WEIGHT: (B)(6) KILOGRAMS (KG), HEIGHT: 104 CENTIMETERS (CM), GENDER: UNKNOWN.

  Patient problems: Hydrocephalus

  MAUDE report 12832700 ↗
• InjurySep 28, 2021Mechanical Problem; Mechanical Problem

  ACCORDING TO THE COMPLAINANT A PROGAV HAD A MALFUNCTION POSTOPERATIVELY. THE PATIENT WAS ORIGINALLY IMPLANTED ON (B)(6) 2013 . READJUSTMENT WAS NOT POSSIBLE. THE REVISION DATE WAS (B)(6) 2016. THE VALVE WAS EXPLANTED AND RETURNED TO THE MANUFACTURER FOR EVALUATION. FURTHER DETAILS WERE NOT PROVIDED. HEIGHT:(B)(6).

  Patient problems: Hydrocephalus

  MAUDE report 12540360 ↗