M.BLUE FX815TRecalls & reported problems
Aesculap AG · M.BLUE 0 SYS W/PED.CONTROL RESERVOIR · Class 2 · Implant
All models of M.BLUE (18)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04041906504519), received between May 5, 2022 and Nov 24, 2025 — classified as 3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Infusion or Flow Problem3
- Mechanical Problem1
Patient problems
- Hydrocephalus3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 24, 2025Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A M.BLUE PLUS (#FX815T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. ACCORDING TO THE COMPLAINANT, THE VALVE WAS MALFUNCTIONED. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2025. THE COMPLAINED PRODUCT WILL BE SENT TO THE MANUFACTURER FOR INVESTIGATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.
Patient problems: Hydrocephalus
MAUDE report 23631175 ↗InjuryMay 11, 2023Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A M.BLUE (#FX815T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN 2022. ACCORDING TO THE COMPLAINANT, THE SHUNT SHOWED AN OVERDRAINAGE AND ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED IN (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, 5 MONTHS, WEIGHT: 14 KILOGRAMS (KG) , HEIGHT: 70-80 CENTIMETERS (CM), GENDER: FEMALE. SAME EVENT AS #3004721439-2023-00120.
Patient problems: Hydrocephalus
MAUDE report 16915546 ↗InjuryMay 5, 2022Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT AN M. BLUE (PART # FX815T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE DEVICE WAS BELIEVED TO BE BLOCKED. THE COMPLAINT DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION HAS BEEN MADE AVAILABLE.
Patient problems: Hydrocephalus
MAUDE report 14288095 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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