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M.BLUE FX840TRecalls & reported problems

Aesculap AG · M.BLUE 0 SYS W/SPRUNG RESERVOIR · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04041906504717), received between Aug 25, 2023 and Aug 25, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Infusion or Flow Problem” (1 report).

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

Device problems

  • Infusion or Flow Problem1
  • Mechanical Problem1

Patient problems

  • Hydrocephalus1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 25, 2023Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

    IT WAS REPORTED THAT A M.BLUE (#FX840T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE SHUNT SHOWED AN OVER-DRAINAGE, 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: 53 YEARS. WEIGHT: 111 KILOGRAMS (KG). HEIGHT: 185 CENTIMETERS (CM). GENDER: MALE.

    Patient problems: Hydrocephalus

    MAUDE report 17627264 ↗

Other Shunt, central nervous system and components devices

All Shunt, central nervous system and components devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.