M.BLUE FX817TRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04041906504533), received between Apr 5, 2021 and Apr 19, 2023 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Infusion or Flow Problem” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 19, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED TO AESCULAP INC. THAT A M.BLUE 10 SYS W/PED.CONTROL RESERVOIR (PRODUCT # FX817T) WAS IMPLANTED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE DEVICE WAS BELIEVED TO HAVE A BLOCKAGE. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2023. THE COMPLAINT DEVICE WAS 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 XC (B)(4).

  Patient problems: Hydrocephalus

  MAUDE report 16770406 ↗
• InjuryApr 19, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A M.BLUE SHUNT SYSTEM (PART # FX647T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE SYSTEM WAS BELIEVED TO BE OPERATED IN BLOCKAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON (B)(6) 3023. THE COMPLAINT DEVICE HAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.

  Patient problems: Hydrocephalus

  MAUDE report 16769893 ↗
• MalfunctionJul 20, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A M.BLUE (PART # FX817T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE MBLUE10 SHUNT HAD INADVERTENTLY REPROGRAMMED. IN EARLY JUNE, THE VALVE WAS ADJUSTED TO EIGHT (8). WHEN THE PATIENT RETURNED ON (B)(6) 2021, THE VALVE VERIFIED AT 16 (SIXTEEN). THE VALVE WAS ADJUSTED BACK TO EIGHT (8) AND THE SETTING WAS VERIFIED WITH BOTH COMPASSES. ON (B)(6) 2022 THE PATIENT RETURNED FOR FOLLOW-UP AND THE VALVE SETTING REMAINED AT EIGHT (8), WHICH WAS THE PRIOR SETTING. NO FURTHER ADJUSTMENTS WERE MADE DURING THIS VISIT. THE PATIENT WAS SCHEDULED TO UNDERGO A T WAS TO UNDERGO A COMPUTED TOMOGRAPHY (CT) SCAN AND SHUNTOGRAM. THE COMPLAINT DEVICE IS STILL IMPLANTED AND NOT YET AVAILABLE FOR FURTHER EVALUATION. THE PATIENT IS SCHEDULED FOR CLINICAL FOLLOW-UP.

  Patient problems: Hydrocephalus

  MAUDE report 15066852 ↗
• InjuryJul 20, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A M.BLUE (PART # FX817T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE MBLUE10 SHUNT HAD INADVERTENTLY REPROGRAMMED. IN EARLY (B)(6), THE VALVE WAS ADJUSTED TO EIGHT (8). WHEN THE PATIENT RETURNED ON (B)(6) 2021, THE VALVE VERIFIED AT 16 (SIXTEEN). THE VALVE WAS ADJUSTED BACK TO EIGHT (8) AND THE SETTING WAS VERIFIED WITH BOTH COMPASSES. ON (B)(6) 2022 THE PATIENT RETURNED FOR FOLLOW-UP AND THE VALVE SETTING REMAINED AT EIGHT (8), WHICH WAS THE PRIOR SETTING. NO FURTHER ADJUSTMENTS WERE MADE DURING THIS VISIT. THE PATIENT WAS SCHEDULED TO UNDERGO A COMPUTED TOMOGRAPHY (CT) SCAN AND SHUNTOGRAM. THE COMPLAINT DEVICE IS STILL IMPLANTED AND NOT YET AVAILABLE FOR FURTHER EVALUATION. THE PATIENT IS SCHEDULED FOR CLINICAL FOLLOW-UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15066821 ↗
• InjuryApr 5, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A M.BLUE SHUNTSYSTEM WAS IMPLANTED. ACCORDING TO THE COMPLAINANT, THE VALVE IS REPORTED TO HAVE SHOWN BLOCKAGE DURING THE USE. THE PATIENT UNDERWENT A REVISION PROCEDURE.

  Patient problems: Hydrocephalus

  MAUDE report 11616230 ↗