M.BLUE FX812TRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04041906504496), received between Dec 15, 2022 and Dec 9, 2024 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Mechanical 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 16, 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.

• InjuryDec 9, 2024Excess Flow or Over-Infusion; Physical Resistance/Sticking; Excess Flow or Over-Infusion; Physical Resistance/Sticking

  IT WAS REPORTED THAT AN M.BLUE (#FX812T) 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 20877868 ↗
• InjuryJul 3, 2024Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A M.BLUE (#FX816T) 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: 17 YEARS. HEIGHT: 160 CM. WEIGHT: 49,1 KG. GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 19671042 ↗
• InjuryJul 3, 2024Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A M.BLUE (#FX812T) 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 DISPOSED OF BY THE CLINIC. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.

  Patient problems: Hydrocephalus

  MAUDE report 19670896 ↗
• MalfunctionJun 2, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A M.BLUE (#FX812T) VALVE WAS TO BE IMPLANTED. THE COMPLAINANT DESCRIBED THAT THE VALVE IS BLOCKED DURING THE ADJUSTMENT BEFORE USING. DURING THE ADJUSTMENT PROCESS, THE HOUSING MEMBRANE BLOCKED IN THE DEPRESSED CONDITION AND DID NOT RETURN INTO THE ORIGINAL POSITION. ANOTHER PRODUCT WAS USED AND THE OPERATION WAS PERFORMED SUCCESSFULLY.

  Patient problems: Hydrocephalus

  MAUDE report 17051425 ↗
• InjuryDec 15, 2022Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A M.BLUE (PART # FX812T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE DIFFICULT TO ADJUST AND OPERATE IN OVER-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: 72 YEARS. HEIGHT: 170 CENTIMETERS (CM). WEIGHT: 65 KILOGRAMS (KG). GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 15990196 ↗