M.BLUE FX827TRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04041906504618), received between Oct 10, 2023 and Aug 17, 2026 — classified as 6 injuries.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 17, 2026Obstruction of Flow

  It was reported that an M.blue Shuntsystem (#FX827T) was implanted.According to the complainant, the shunt system caused a malfunction.The patient underwent a revision procedure.

  Patient problems: Hydrocephalus

  MAUDE report 50275055 ↗
• InjuryJun 23, 2026Obstruction of Flow; Physical Resistance/Sticking

  IT WAS REPORTED THAT AN M.BLUE SHUNTSYSTEM (#FX827T) WAS IMPLANTED ON (B)(6) 2025. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM POSSIBLY CAUSED AN UNDERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2026.

  Patient problems: Hydrocephalus

  MAUDE report 25594425 ↗
• InjuryOct 27, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT AN M BLUE SHUNT SYSTEM (#FX827T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM 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 PRODUCT WAS SENT TO THE MANUFACTURER FOR INVESTIGATION.

  Patient problems: Hydrocephalus

  MAUDE report 23391289 ↗
• InjurySep 27, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT AN M. BLUE SHUNT SYSTEM (#FX827T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM SHOWED AN UNDER-DRAINAGE/BLOCKAGE. 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: 73 YEARS. WEIGHT: 75 KGS. HEIGHT: 175 CM.

  Patient problems: Hydrocephalus

  MAUDE report 20320843 ↗
• InjuryNov 1, 2023Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A M.BLUE (#FX827T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE SHUNT SHOWED A UNDER-DRAINAGE AND ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON (B)(6) 2023. THE COMPLAINANT DEVICE HAS NOT YET RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 75 YEARS; WEIGHT: 61 KILOGRAMS; HEIGHT: 160 CENTIMETERS; GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 18048704 ↗
• InjuryOct 10, 2023Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A M.BLUE (#FX827T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE VALVE 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: 67 YEARS, HEIGHT: 164 CENTIMETERS, WEIGHT: 78.5 KILOGRAMS, GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 17905668 ↗