PaediGAV® FV288TRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04041906113001), received between May 7, 2021 and May 18, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Infusion or Flow 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 18, 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.

• InjuryMay 18, 2026Infusion or Flow Problem

  IT WAS REPORTED THAT A PAEDIESA VALVE (#FV288T) WAS IMPLANTED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN OVER-DRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2026. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. SAME EVENT AS #: 3004721439-2026-00141.

  Patient problems: Hydrocephalus

  MAUDE report 25200135 ↗
• InjuryJan 27, 2023Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A SHUNTASSISTANT (PART # FV288T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE VALVE IN COMBINATION WITH A PROGAV 2.0 WAS BELIEVED TO BE OPERATING IN OVERDRAINAGE. 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: 17 YEARS, HEIGHT: 153 CENTIMETERS (CM), WEIGHT: 57 KILOGRAMS (KG), GENDER: FEMALE. SAME EVENT AS MEDWATCH#3004721439-2022-00435 AND 3004721439-2022-00436.

  Patient problems: Hydrocephalus

  MAUDE report 16258210 ↗
• InjuryJan 7, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PAEDI SHUNTASISSTANT (PART # FV288T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO HAVE A SHUNT DYSFUNCTION. 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: (B)(6), HEIGHT: 148 CENTIMETERS (CM), WEIGHT: (B)(6) GENDER: UNKNOWN. ITS SAME PATIENT AS MDR ID #3004721439-2021-00345 AND MDR ID # 3004721439-2021-00347.

  Patient problems: Hydrocephalus

  MAUDE report 13193800 ↗
• InjuryDec 2, 2021Mechanical Problem; Mechanical Problem

  ACCORDING TO THE COMPLAINANT A SHUNT ASSISTANT WAS NOT FUNCTIONING AS EXPECTED. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS NOT WORKING PROPERLY WHEN PUT TOGETHER AND INLINE, BUT EACH COMPONENT (RESERVOIR, VALVE, & SHUNT ASSIST) SEEMED TO WORK INDIVIDUALLY. THE SURGEON TOOK OUT THE VALVE SYSTEM AND REPLACED IT WITH ALL NEW COMPONENTS OF THE SAME PRODUCT. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. FURTHER DETAILS WERE NOT PROVIDED. WEIGHT: (B)(6). ASSOCIATED MEDWATCH: 3004721439-2021-00765.

  Patient problems: Hydrocephalus

  MAUDE report 12919455 ↗
• InjuryMay 7, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PAEDISA (#FV288T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN 2011 . ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE OPERATING IN UNDERDRIANAGE. THE VENTRICLE WERE NARROWED. 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: (B)(6), HEIGHT:142 CM, WEIGHT: (B)(6). GENDER: FEMALE. SAME EVENT: MEDWATCH 3004721439-2021-00106.

  Patient problems: Hydrocephalus

  MAUDE report 11790192 ↗