GAV 2.0 FX214TRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04041906500047), received between May 24, 2023 and Oct 28, 2024 — classified as 9 injuries.

The most frequently reported specific device problem is “Infusion or Flow Problem” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryOct 28, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT A GAV 2.0 (#FX214T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE COMPLAINANT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hydrocephalus

  MAUDE report 20546222 ↗
• InjuryJul 30, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A GAV 2.0 (#FX214T) WAS IMPLANTED DURING A PROCEDURE ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE VALVE WAS EXPLANTED DUE TO A BLOCKAGE. 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: 1 YEARS, 2 MONTHS WEIGHT: 5 KGS, HEIGHT: UNKNOWN, GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 19860602 ↗
• InjuryJul 30, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A GAV 2.0 (#FX211T) WAS IMPLANTED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, THE VALVE WAS EXPLANTED DUE TO A BLOCKAGE. THE COMPLAINANT DEVICE WILL BE RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.

  Patient problems: Hydrocephalus

  MAUDE report 19860601 ↗
• InjuryJun 10, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A GAV 2.0 (#FX214T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM HAD A MALFUNTION. NO FURTHER INFORMATION WERE GIVEN VIA THE QUESTIONNAIRE. 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. NO PATIENT DATA AVAILABLE.

  Patient problems: Hydrocephalus

  MAUDE report 19499592 ↗
• InjuryJun 10, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A GAV 2.0 (#FX214T) 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: 4 YEARS WEIGHT: 19 KG GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 19499362 ↗
• InjuryJun 10, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A GAV 2.0 (#FX214T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM 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: 3 MONTHS HEIGHT: 40 CM WEIGHT: 3 KG GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 19498495 ↗
• InjuryOct 17, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A GAV 2.0 VALVE 10/25 (FX214T) WAS IMPLANTED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE BLOCKED. 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. NO PATIENT DATA WERE SUBMITTED.

  Patient problems: Hydrocephalus

  MAUDE report 17949672 ↗
• InjuryMay 24, 2023Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT A GAV 2.0 (#FX214T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE PATIENT WAS BROUGHT BACK FOR OTHER UNSPECIFIED COMPLICATIONS. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT THE COMPLICATIONS WERE UNRELATED TO THE SHUNT TREATMENT. HOWEVER, THE PHYSICIAN BELIEVED ADDITIONAL DRAINAGE WAS NEEDED, AND PLANNED TO SWAP THE DEVICE WITH A PROGRAMMABLE VALVE. DURING THE REVISION SURGERY, WHEN THE SHUNT WAS CHECKED IT DID NOT "MOVE THE MANOMETER WITH DISTAL CATHETER STILL IN PLACE." HOWEVER, THE MANOMETER DRAINED AT A NORMAL RATE AFTER THE VALVE WAS REMOVED WITH JUST THE DISTAL CATHETER IN PLACE (STILL IN THE ABDOMEN).THE DEVICE WAS REPLACED WITH ANOTHER MANUFACTURER'S DEVICE. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16995560 ↗
• InjuryMay 24, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A GAV 2.0 (#FX214T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE PATIENT WAS BROUGHT BACK FOR OTHER UNSPECIFIED COMPLICATIONS. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT THE COMPLICATIONS WERE UNRELATED TO THE SHUNT TREATMENT. HOWEVER, THE PHYSICIAN BELIEVED ADDITIONAL DRAINAGE WAS NEEDED, AND PLANNED TO SWAP THE DEVICE WITH A PROGRAMMABLE VALVE. DURING THE REVISION SURGERY, WHEN THE SHUNT WAS CHECKED IT DID NOT "MOVE THE MANOMETER WITH DISTAL CATHETER STILL IN PLACE." HOWEVER, THE MANOMETER DRAINED AT A NORMAL RATE AFTER THE VALVE WAS REMOVED WITH JUST THE DISTAL CATHETER IN PLACE (STILL IN THE ABDOMEN).THE DEVICE WAS REPLACED WITH ANOTHER MANUFACTURER'S DEVICE. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.

  Patient problems: Hydrocephalus

  MAUDE report 16992609 ↗