M.BLUE FX802TRecalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 04041906504410), received between Apr 15, 2021 and May 18, 2026 — classified as 44 injuries, 1 malfunction.

The most frequently reported specific device problem is “Infusion or Flow Problem” (38 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

• InjuryMay 18, 2026Obstruction of Flow; Physical Resistance/Sticking

  IT WAS REPORTED THAT AN M. BLUE VALVE(#FX802T) WAS IMPLANTED ON (B)(6) 2025. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN UNDER-DRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2026. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.

  Patient problems: Hydrocephalus

  MAUDE report 25200229 ↗
• InjuryApr 20, 2026Infusion or Flow Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT A M. BLUE (#FX802T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN OVERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2026. 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 24927687 ↗
• MalfunctionApr 20, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT A M.BLUE (#FX802T) WAS NOT ADJUSTABLE BEFORE USE. THE PRODUCT RETURNED IN OPENED STERILE PACKAGING. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE MALFUNCTION. THE SHUNT WAS RETURNED FOR EXAMINATION TO THE MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24927196 ↗
• InjurySep 11, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT AN M.BLUE VALVE (#FX802T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED 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 PRODUCT WAS SENT TO THE MANUFACTURER FOR INVESTIGATION.

  Patient problems: Hydrocephalus

  MAUDE report 23025088 ↗
• InjuryApr 28, 2025Infusion or Flow Problem; Physical Resistance/Sticking; Infusion or Flow Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT A M.BLUE (#FX802T) WAS IMPLANTED. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN OVERDRAINAGE AND HAD ADJUSTMENT PROBLEMS. THE PATIENT UNDERWENT A REVISION PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE COMPLAINED PRODUCT WAS SENT TO THE MANUFACTURER FOR INVESTIGATION.

  Patient problems: Hydrocephalus

  MAUDE report 21917139 ↗
• InjuryFeb 18, 2025Infusion or Flow Problem; Physical Resistance/Sticking; Infusion or Flow Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT AN M. BLUE (#FX802T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. 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.

  Patient problems: Hydrocephalus

  MAUDE report 21398074 ↗
• InjuryFeb 18, 2025Infusion or Flow Problem; Physical Resistance/Sticking; Infusion or Flow Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT AN M. BLUE (#FX802T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2020. 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. SAME EVENT/PATIENT AS #3004721439-2025-00033.

  Patient problems: Hydrocephalus

  MAUDE report 21397535 ↗
• InjuryFeb 18, 2025Infusion or Flow Problem; Physical Resistance/Sticking; Infusion or Flow Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT AN M. BLUE (#FX802T) 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 21396732 ↗
• InjuryDec 30, 2024Infusion or Flow Problem; Physical Resistance/Sticking; Infusion or Flow Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT AN M.BLUE (#FX802T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024. 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 21034701 ↗
• InjuryDec 30, 2024Infusion or Flow Problem; Physical Resistance/Sticking; Infusion or Flow Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT A M.BLUE (#FX802T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE ALVE CAUSED AN OVERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024. 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 21034331 ↗
• InjuryMar 15, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A M. BLUE (#FXT802) AND A PED.PRECHAMBER (#FV035T) WERE IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. 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: 10 YEARS HEIGHT: 145 CM WEIGHT: 35 KG GENDER: FEMALE SAME EVENT AS MEDWATCH#3004721439-2024-00068.

  Patient problems: Hydrocephalus

  MAUDE report 18911981 ↗
• InjuryFeb 22, 2024Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A M.BLUE (#FX802T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE M.BLUE 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: 2 YEARS HEIGHT: 103 CM WEIGHT: 18 KG GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 18763209 ↗
• InjuryFeb 2, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A M.BLUE (#FX802T) 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) 2023. THE COMPLAINANT DEVICE HAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 16 MONTHS . GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 18634329 ↗
• InjuryFeb 2, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A M.BLUE (#FX802T) 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) 2023. THE COMPLAINANT DEVICE HAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 3 YEARS. GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 18634277 ↗
• InjuryDec 18, 2023Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A M.BLUE (#FX802T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE OPERATED IN 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: 3 YEARS, HEIGHT: 96 CM, WEIGHT: 13 KG, GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 18347313 ↗
• InjuryDec 15, 2023Infusion or Flow Problem; Insufficient Device Problem Information; Infusion or Flow Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT A M.BLUE PLUS (#FX802T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE VALVE SHOWED AN UNDER-DRAINGE. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON (B)(6) 2023. THE COMPLAINANT DEVICE HAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 3 YEARS, 3 MONTHS WEIGHT: 16 KGS HEIGHT: 97 CM GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 18336157 ↗
• InjuryDec 14, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A M.BLUE PLUS (#FX802T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE VALVE SHOWED AN UNDER-DRAINGE. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON (B)(6) 2023. THE COMPLAINANT DEVICE HAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 3 YEARS, 3 MONTHS . WEIGHT: 16 KGS. HEIGHT: 97 CM. GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 18330636 ↗
• InjuryDec 1, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IMPLANTATION: (B)(6) 2019 EXPLANTATION: (B)(6) 2023. FILE ENTERED WITH LIMITED INFORMATION: DELIVERED IN RETURN KIT IN UNKNOWN LIQUID. AGE Y: 4 / WEIGHT KG: 17.6 / HEIGH CM: 106 / GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 18248536 ↗
• InjuryNov 1, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A M.BLUE (#FX805T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON UNKNOWN. ACCORDING TO THE COMPLAINANT, THE SHUNT SHOWED A UNDER-DRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON UNKNOWN. THE COMPLAINANT DEVICE HAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 7 YEARS. WEIGHT: 35 KILOGRAMS. HEIGHT: 123 CENTIMETERS. GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 18048299 ↗
• InjuryOct 20, 2023Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A M.BLUE (#FX802T) WAS IMPLANTED DURING A PROCEDURE PERFORMED. ACCORDING TO THE COMPLAINANT, THE VALVE IS NOT ABLE TO BE REPROGRAMMED EXTERNALLY. THE MEMBRANE OF THE VALVE SEEMS TO BE STUCK IN THE PRESSED POSITION. THE HUMP OF THE VALVE CANNOT BE FELT, NOR CAN IT BE HEARD OR FELT TO CLICK. THE VALVE DOES NOT CHANGE ITS RESISTANCE WHEN IT IS TRIED TO BE REPROGRAMMED. BASED ON X-RAYS AND PROGRAMMING TOOLS, AND THE FACT THAT THE PATIENT HAS NO ADVERSE EFFECTS, THE CLINIC IS CONFIDENT THAT THE VALVE IS IMPLANTED CORRECTLY. THE PATIENT UNDERGOES A REVISION PROCEDURE. THE COMPLAINED DEVICE WILL BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hydrocephalus

  MAUDE report 17975882 ↗
• InjuryOct 20, 2023Mechanical Problem; Mechanical Problem

  MINOR UPDATE TO B5 (SPELLING). IT WAS REPORTED TO AESCULAP INC. THAT AN M.BLUE 10 VALVE (PART # FX802T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE VALVE WAS NOT ABLE TO BE EXTERNALLY ADJUSTED. THE MEMBRANE OF THE VALVE SEEMS TO BE STUCK IN THE DEPRESSED POSITION. THE VALVE WAS NOT ABLE TO BE FELT UNDER THE PATIENT'S SKIN, AND NO AUDIBLE CLICK WAS PRESENT. ADDITIONALLY, THE VALVE SETTING REMAINS THE SAME AFTER ATTEMPTING TO REPROGRAM. THE CLINIC IS CONFIDENT THAT THE VALVE IS IMPLANTED CORRECTLY, BASED ON X-RAYS, THE REPROGRAMMING TOOLS, AND SINCE THE PATIENT HAS NOT EXPERIENCED ANY ADVERSE EFFECTS. THE PATIENT WILL UNDERGO A REVISION SURGERY; HOWEVER, THE SURGERY DATE HAS NOT BEEN PROVIDED. THE COMPLAINT DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4).

  Patient problems: Hydrocephalus

  MAUDE report 17975522 ↗
• InjuryJul 14, 2023Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A M.BLUE (#FX802T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, THE SHUNT SHOWED AN OVER-DRAINAGE AND ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON (B)(6) 2023. THE COMPLAINT DEVICE HAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 4 YEARS, WEIGHT: 13 KILOGRAMS (KG) HEIGHT: 99 CENTIMETERS (CM) GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 17330135 ↗
• InjuryJul 5, 2023Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A M.BLUE (#FX802T) 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 COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 4 YEARS HEIGHT: 96 CENTIMETERS (CM) WEIGHT: 13 KILOGRAMS (KG) GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 17262356 ↗
• InjuryJun 6, 2023Infusion or Flow Problem; Infusion or Flow Problem

  INVESTIGATION COMPLETE.

  Patient problems: Insufficient Information

  MAUDE report 17074856 ↗
• InjuryJun 6, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A M.BLUE (#FX802T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM (SPRUNG RESERVOIR + M.BLUE) SHOWED A DRAINAGE PROBLEM. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINT DEVICES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE RELEASE FOR INVESTIGATION IS MISSING, SO THE EXAMINATION COULD NOT BE STARTED. SAME EVENT AS MEDWATCH#3004721439-2023-00170.

  Patient problems: Hydrocephalus

  MAUDE report 17072180 ↗