M.BLUE FX803TRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 04041906504427), received between Jan 14, 2022 and Jul 3, 2025 — classified as 18 injuries.

The most frequently reported specific device problem is “Infusion or Flow Problem” (15 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryJul 3, 2025Infusion or Flow Problem; Physical Resistance/Sticking; Infusion or Flow Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT AN M.BLUE (#FX803T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2025. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE COMPLAINED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hydrocephalus

  MAUDE report 22394325 ↗
• InjuryJan 27, 2025Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A M.BLUE (#FX803T) WAS IMPLANTED. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN OVERDRAINAGE. 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.

  Patient problems: Hydrocephalus

  MAUDE report 21242582 ↗
• InjuryDec 9, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A M.BLUE(#FX803T) WAS IMPLANTED DURING A PROCEDURE. 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

  Patient problems: Hydrocephalus

  MAUDE report 20877840 ↗
• InjuryDec 9, 2024Use of Device Problem; Physical Resistance/Sticking; Use of Device Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT A M.BLUE(# FX803T) WAS IMPLANTED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, THE VALVE SHOWED A DYSFUNCTION (ADJUSTMENT DIFFICULTIES). 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.

  Patient problems: Hydrocephalus

  MAUDE report 20877682 ↗
• InjuryAug 27, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT AN M. BLUE (#FX803T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE VALVE SHOWED AN UNDER-DRAINAGE. 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: 6 YEARS, 10 MONTHS WEIGHT: 18 KGS HEIGHT: 111 CM GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 20074687 ↗
• InjuryAug 27, 2024Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A M.BLUE (#FX803T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. 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: 14 YEARS. HEIGHT: 183 CM. WEIGHT: 99 KG. GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 20074583 ↗
• InjuryJul 25, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT AN M.BLUE VALVE (#FX803T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE VALVE SHOWED AN OVER-DRAINAGE. 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: 14 YEARS, 4 MONTHS. WEIGHT: 98 KGS. HEIGHT: 179 CM. GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 19827503 ↗
• InjuryMay 24, 2024Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A M. BLUE (#FX803T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN OVERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. 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: 118 CM WEIGHT: 20 KG GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 19394357 ↗
• InjuryApr 17, 2024Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A M.BLUE VALVE (#FX803T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE VALVE SHOWED AN OVER-DRAINAGE AND ADJUSTMENT DIFFICULTIES. 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: 14 YEARS, 1 MONTHS WEIGHT: 107 KGS HEIGHT: 179 CM GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 19126862 ↗
• InjuryMay 11, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A M.BLUE (#FX803T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED 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: 36 YEARS. HEIGHT: 170 CENTIMETERS (CM). WEIGHT: 80 KILOGRAMS (KG). GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 16914866 ↗
• InjuryMar 17, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A M.BLUE (PART # FX803T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THEVALVE WAS BELIEVED TO BE OPERATED IN OVERER-DRAINAGE. 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: 10 YEARS, HEIGHT: 128 CENTIMETERS (CM), WEIGHT: 38 KILOGRAMS (KG). GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 16568462 ↗
• InjuryMar 8, 2023Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A M.BLUE (PART # FX803T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN UNDERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. 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: 6 YEARS. HEIGHT: 120 CENTIMETERS (CM). WEIGHT: 30 KILOGRAMS (KG). GENDER: MALE. SAME EVENT AS MEDWATCH # 3004721439-2023-00040.

  Patient problems: Hydrocephalus

  MAUDE report 16507769 ↗
• InjuryNov 22, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A M.BLUE (PART # FX803T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2020. 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: 17 YEARS AND 4 MONTHS. HEIGHT: 178 CENTIMETERS (CM). WEIGHT: 60 KILOGRAMS (KG). GENDER: MALE. SAME EVENT AS MEDWATCH #: 3004721439-2022-00348.

  Patient problems: Hydrocephalus

  MAUDE report 15848046 ↗
• InjuryAug 30, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A M.BLUE (PART # FX803T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED 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: 8 YEARS; HEIGHT: 125 CENTIMETERS (CM); WEIGHT: 30 KILOGRAMS (KG); GENDER: MALE. SAME EVENT AS MEDWATCH-NO. 3004721439-2022-00269.

  Patient problems: Hydrocephalus

  MAUDE report 15324979 ↗
• InjuryAug 30, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A M.BLUE (PART # FX803T) 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 AN UNKNOWN DATE. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 8 YEARS, HEIGHT: 129 CENTIMETERS (CM), WEIGHT: 28 KILOGRAMS (KG), GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 15324282 ↗
• InjuryAug 30, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A M.BLUE VALVE (PART # FX803T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE IN UNDERDRAINAGE. 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: 8 YEARS HEIGHT: 129 CENTIMETERS (CM) WEIGHT: 28 KILOGRAMS (KG) GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 15324255 ↗
• InjuryJun 14, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A M.BLUE (#FX803T) WAS IMPLANTED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE OPERATED IN 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: 15 YEARS, HEIGHT: 170 CM, WEIGHT: 60 KG, GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 14691255 ↗
• InjuryJan 14, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A M. BLUE 15 VALVE (PART # FX803T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE DIFFICULT TO ADJUST. 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: 163 CENTIMETERS (CM), WEIGHT: (B)(6), GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 13261499 ↗