proGAV 2.0® FX411TRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04041906136536), received between Nov 10, 2021 and Dec 22, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Infusion or Flow Problem” (3 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.

• InjuryDec 22, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 (PART # FX411T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNSPECIFIED DATE IN 2019. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE OPERATING IN OVER-DRAINAGE AND WAS NON-ADJUSTABLE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022. 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 16038066 ↗
• InjuryDec 21, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 (PART#: FX411T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNSPECIFIED DATE IN 2019. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE OPERATING IN OVER-DRAINAGE AND WAS NON-ADJUSTABLE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022. 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 16029922 ↗
• InjuryNov 10, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED MIETHKE THAT A PROGAV 2.0 WITH SHUNTASSISTANT 10 (PART # FX411T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE PATIENT RETURNED FOR SURGERY APPROXIMATELY TWELVE (12) MONTHS AFTER THE VALVE WAS IMPLANTED. THE PHYSICIAN SUSPECTED A DISTAL OR PROXIMAL OCCLUSION. REPORTEDLY, A MANOMETER WAS USED ON EACH SIDE OF THE VALVE, THE VALVE WAS THEN CHECKED WITH A CHECKMATE TO CONFIRM ITS SETTING WAS AT TEN (10). ONCE THE SETTING WAS CONFIRMED, THE PHYSICIAN INJECTED SALINE, WHICH REVEALED THAT THE PROGAV ALLOWED COMPLETE FLOW THROUGH WITHOUT THE SETTING HAVING ANY AFFECT ON FLOW. AT THIS TIME, THE DECISION WAS MADE TO REPLACE THE VALVE. THE EXISTING RESERVOIR WAS LEFT IN PLACE AND A NEW VALVE (PART # FX412T) WAS IMPLANTED AT A SETTING OF TEN (10). THE PHYSICIAN THEN ABLE TO SUCCESSFULLY PERFORM A FLOW RETEST. 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 12787580 ↗