GAV 2.0 FX210TRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04041906500009), received between Nov 19, 2021 and Nov 4, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Infusion or Flow Problem” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2025Infusion or Flow Problem; Infusion or Flow Problem

  THE INVESTIGATION OF THE VALVE HAS BEEN COMPLETED.

  Patient problems: Hydrocephalus

  MAUDE report 23463427 ↗
• InjuryMay 18, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT AN GAV 2.0 (PART # FX210T) WAS IMPLANTED DURING A PROCEDURE IN (B)(6) 2021. ACCORDING TO THE COMPLAINANT, INITIALLY THE SHUNT WAS NOTED TO BE OVERDRAINING AND THE SHUNT PRESSURE WAS LOW BUT DURING POST OPERATIVE VISITS IT WAS NOTED THAT THE DEVICE DID NOT SEEM TO BE DRAINING. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022 WHEN THE SHUNT WAS CYCLED WITH SALINE THE SURGEON NOTED THAT THE SALINE COULD NOT GO THROUGH THE DEVICE. THE PATIENT WAS IMPLANTED WITH A NEW M.BLUE DEVICE AND THERE WERE NO INTRAOPERATIVE EVENTS THAT OCCURED DURING THE PLACEMENT OF THE NEW VALVE. THE COMPLAINT DEVICE HAS BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hydrocephalus

  MAUDE report 14431426 ↗
• InjuryMay 7, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED TO AESCULAP INC. THAT A GAV 2.0 VALVE 5/20 (PART # FX210T ) WAS IMPLANTED DURING A PRIMARY PROCEDURE PERFORMED IN (B)(6) 2021. ACCORDING TO THE COMPLAINANT, INITIALLY THE SHUNT WAS NOTED TO BE OVERDRAINING AND THE SHUNT PRESSURE WAS LOW BUT DURING POST OPERATIVE VISITS IT WAS NOTED THAT THE DEVICE DID NOT SEEM TO BE DRAINING. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022 WHEN THE SHUNT WAS CYCLED WITH SALINE THE SURGEON NOTED THAT THAT THE SALINE COULD NOT GO THROUGH THE DEVICE. THE PATIENT WAS IMPLANTED WITH A NEW M.BLUE DEVICE, THERE WERE NO INTRAOPERATIVE EVENTS THAT OCCURED DURING THE PLACEMENT OF THE NEW VALVE. THE COMPLAINT DEVICE HAS NOT BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. THE MALFUNCTION IS FILED UNDER AIC REFERENCE (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 14320233 ↗
• InjuryDec 2, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A GAV 2.0 VALVE 5/20 (PART # FX210T) WAS IMPLANTED DURING A PRIMARY PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE VALVE WAS SUSPECTED OF BEING OCCLUDED. THE PATIENT UNDERWENT A REVISION PROCEDURE ON AN UNKNOWN DATE. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. AT THIS TIME, THERE IS LIMITED INFORMATION AS TO METHOD OF INTERVENTION PERFORMED TO RESOLVE THE BLOCKAGE. THE MALFUNCTION IS FILED UNDER REFERENCE (B)(4).

  Patient problems: Hydrocephalus; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12917087 ↗
• InjuryNov 19, 2021Infusion or Flow Problem; Infusion or Flow Problem

  NO UPDATES NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12844105 ↗