GAV 2.0 FX215TRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04041906500054), received between May 7, 2021 and Nov 6, 2025 — classified as 10 injuries.

The most frequently reported specific device problem is “Infusion or Flow Problem” (10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryNov 6, 2025Infusion or Flow Problem; Infusion or Flow Problem

  ACCORDING TO THE COMPLAINANT THE SURGEON HAD PREVIOUSLY IMPLANTED VALVE IN PATIENT AND SHUNT WAS NOT DRAINING AT A RATE SURGEON FELT WAS APPROPRIATE. REPORTEDLY THE PRESSURE SETTING WAS TOO HIGH FOR PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.

  Patient problems: Failure of Implant

  MAUDE report 23486109 ↗
• InjuryNov 4, 2025Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A GAV 2.0 (#FX215T) WAS IMPLANTED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED DRAINAGE PROBLEM. DEEMED PRESSURE SETTING WAS TOO HIGH FOR PATIENT. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINED PRODUCT WAS SENT TO THE MANUFACTURER FOR INVESTIGATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. SAME PATIENT AS MEDWATCH# 3004721439-2025-00333.

  Patient problems: Hydrocephalus

  MAUDE report 23463426 ↗
• InjuryJul 1, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A GAV 2.0 (#FX215T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN UNDERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINANT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 7 YEARS, 11 MONTHS.

  Patient problems: Hydrocephalus

  MAUDE report 19644241 ↗
• InjuryDec 15, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A GAV 2.0 (#FX215T) WAS IMPLANTED DURING A PROCEDURE IN (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN OVERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINANT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 28 YEARS, HEIGHT: 167 CM, WEIGHT: 68 KG, GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 18334643 ↗
• InjurySep 14, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A GAV 2.0 (#FX215T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE OPERATED IN UNDERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINANT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 1 YEAR AND 2 MONTHS.

  Patient problems: Hydrocephalus

  MAUDE report 17748584 ↗
• InjuryAug 26, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A GAV 2.0 (PART # FX215T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN UNDERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED 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. AGE: 6 YEARS 10 MONTH. HEIGHT: 110 CENTIMETERS (CM). WEIGHT: 16 KILOGRAMS (KG). GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 15306662 ↗
• InjuryJul 20, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A GAV 2.0 (PART # FX215T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN UNDERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED 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 15065859 ↗
• InjuryApr 5, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A MIETHKE GAV 2.0 10/30 VALVE (PART # UNKNOWN) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE BLOCKED AFTER THE PATIENT WAS IN A ROAD TRAFFIC ACCIDENT WITH IMPACT AT THE SHUNT VALVE SITE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022. THE COMPLAINT DEVICE HAD NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. FOLLOW-UP INFORMATION WAS RECEIVED WHICH REVEALED THE FOLLOWING: THE (B)(6) FEMALE PATIENT WITH BACKGROUND CHIARI II MALFORMATION AND HYDROCEPHALUS UNDERWENT REMOVAL OF AN EXTERNAL VENTRICULAR DRAIN (EVD) AND INSERTION OF A VP SHUNT WITH THE MIETHKE GAV 2.0 10/30 VALVE ON (B)(6) 2022. A FEW WEEKS POST-SURGERY, THE PATIENT WAS INVOLVED IN A LOW-SPEED TRAFFIC ACCIDENT IN WHICH A VAN HIT THE PASSENGER SIDE OF THE CAR AT APPROXIMATELY 20 MILES PER HOUR (MPH), WHICH CAUSED HER HEAD TO IMPACT THE CAR DOOR AT THE SITE OF THE SHUNT VALVE. APPROXIMATELY ONE (1) WEEK LATER, THE PATIENT PRESENTED WITH IRRITABILITY AND VOMITING AND WAS TAKEN TO THEATRE FOR SHUNT EXPLORATION (VENTRICLES DID NOT CHANGE ON COMPUTED TOMOGRAPHY (CT) IMAGING WHEN SHUNT BLOCKED), THEREFORE, A RET

  Patient problems: Hydrocephalus

  MAUDE report 14017595 ↗
• InjuryAug 19, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A GAV 2.0 (PART # FX215T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN UNDERDRAINAGE. 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: 41.5 CENTIMETERS (CM). WEIGHT: (B)(6). GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 12341716 ↗
• InjuryMay 7, 2021Infusion or Flow Problem; Infusion or Flow Problem

  ADDITIONAL INFORMATION: GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 11793879 ↗