M.BLUE PLUS FX824TRecalls & reported problems
Aesculap AG · M.BLUE PLUS SYS W/CONTROL RESERVOIR · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Aesculap M.Blue Plus FX824T is an implanted brain shunt system with a control reservoir, used to drain fluid in patients with hydrocephalus. Most of the 51 reports describe drainage flow problems — fluid moving too little or too much, sticking or resisting adjustment, and a catheter that broke off during preparation — often leading to a revision surgery; 48 reports describe injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 51
- Deaths reported
- 0
- Injuries reported
- 48
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 04041906504830), received between May 10, 2021 and Apr 20, 2026 — classified as 48 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Infusion or Flow Problem” (36 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.
Reports received per month
Most reported problems
Device problems
- Infusion or Flow Problem36
- Mechanical Problem10
- Obstruction of Flow7
- Physical Resistance/Sticking7
- Insufficient Device Problem Information2
- Defective Component1
- Human-Device Interface Problem1
- Material Integrity Problem1
Patient problems
- Hydrocephalus47
- No Clinical Signs, Symptoms or Conditions2
- Failure of Implant1
- Pain1
Recent adverse event reports
The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.
InjuryApr 20, 2026Obstruction of Flow
IT WAS REPORTED THAT A M.BLUE PLUS (#FX824T) 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) 2025. THE COMPLAINED PRODUCT WAS SENT TO THE MANUFACTURER FOR INVESTIGATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.
Patient problems: Hydrocephalus
MAUDE report 24931653 ↗MalfunctionApr 20, 2026Physical Resistance/Sticking
IT WAS REPORTED THAT A M.BLUE PLUS (#FX824T) WAS NOT ADJUSTABLE BEFORE USE. THE PRODUCT IS STILL IN THE STERILE PACKAGING AND NO PATIENT INJURY WAS REPORTED AS A RESULT OF TEH MALFUNCTION. THE SHUNT WAS RETURNED FOR EXAMNIATION TO THE MANUFACTURER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24927157 ↗MalfunctionApr 13, 2026Material Integrity Problem
IT WAS REPORTED THAT DURING THE PREPARATION THE VENTRICULAR CATHETER (PART OF #FX824T) WAS BROKEN OFF. THE COMPLAINED PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. ANOTHER SHUNT WAS OPENED AND NO DELAY OR OTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24865581 ↗InjuryApr 13, 2026Obstruction of Flow
IT WAS REPORTED THAT AN M. BLUE PLUS SHUNTSYSTEM (#FX824T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2026. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2026. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE COMPLAINED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: Hydrocephalus
MAUDE report 24860760 ↗InjuryJan 20, 2026Obstruction of Flow; Physical Resistance/Sticking
IT WAS REPORTED THAT A M. BLUE PLUS (#FX824T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. ACCORDING TO THE COMPLAINANT, THE SHUNT CAUSED UNDERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2025. THE COMPLAINED PRODUCT WAS SENT TO THE MANUFACTURER FOR INVESTIGATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.
Patient problems: Hydrocephalus
MAUDE report 24114817 ↗InjuryDec 8, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT AN M.BLUE PLUS (#FX824T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNSPECIFIED DATE. THE USER'S INITIAL REPORT DOES NOT INDICATE ANY PRODUCT MALFUNCTION AS THE REASON FOR EXPLANTATION. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2025. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE COMPLAINED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: Hydrocephalus
MAUDE report 23741999 ↗InjuryAug 25, 2025Infusion or Flow Problem; Physical Resistance/Sticking; Infusion or Flow Problem; Physical Resistance/Sticking
IT WAS REPORTED THAT AN M.BLUE PLUS(#FX824T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVERDRAINAGE AND 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 22882422 ↗InjuryJul 28, 2025Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A M.BLUE VALVE (PART OF AN M.BLUE PLUS SYSTEM) (#FX824T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNSPECIFIED DATE. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2025. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE COMPLAINED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: Hydrocephalus
MAUDE report 22629013 ↗InjuryJul 21, 2025Infusion or Flow Problem; Physical Resistance/Sticking; Infusion or Flow Problem; Physical Resistance/Sticking
IT WAS REPORTED THAT AN M. BLUE PLUS (#FX824T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVERDRAINAGE AND 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 DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: Hydrocephalus
MAUDE report 22554184 ↗InjuryMay 12, 2025Infusion or Flow Problem; Physical Resistance/Sticking; Infusion or Flow Problem; Physical Resistance/Sticking
IT WAS REPORTED THAT AN M. BLUE PLUS (#FX824T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVERDRAINAGE AND 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 22001448 ↗InjuryMar 31, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT AN M. BLUE PLUS(#FX824T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE. 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 21730337 ↗InjuryMar 31, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT A M. BLUE PLUS (#FX824T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE. 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 21730081 ↗InjuryMar 21, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT AN M. BLUE PLUS (#FX824T) WAS IMPLANTED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE. 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 21662389 ↗InjuryMar 10, 2025Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED TO AESCULAP INC. THAT A M. BLUE PLUS SYS W/CONTROL RESERVOIR (PART # FX824T) WAS IMPLANTED ON AN UNSPECIFIED DATE. ACCORDING TO THE COMPLAINANT, THE PATIENT'S VALVE WAS NOT FUNCTIONING PROPERLY. A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2024, AND THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE RETURN KIT QUESTIONNAIRE CONTAINED ADDITIONAL INFORMATION. VALVE OVER-DRAINAGE WAS NOTED PRIOR TO THE REVISION. NO HOUSING DAMAGE WAS OBSERVED POST-REVISION, BUT THE VALVE ADJUSTMENT WAS NOT TESTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4).
Patient problems: Failure of Implant
MAUDE report 21561497 ↗InjuryMar 7, 2025Infusion or Flow Problem; Insufficient Device Problem Information; Infusion or Flow Problem; Insufficient Device Problem Information
IT WAS REPORTED THAT A M. BLUE PLUS (#FX824T) WAS IMPLANTED. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED A OVER-DRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6)2024. 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 21546310 ↗InjuryFeb 24, 2025Obstruction of Flow; Physical Resistance/Sticking; Obstruction of Flow; Physical Resistance/Sticking
IT WAS REPORTED THAT AN M.BLUE PLUS (#FX824T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE AND 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 DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: Hydrocephalus
MAUDE report 21449707 ↗InjuryDec 9, 2024Infusion or Flow Problem; Physical Resistance/Sticking; Infusion or Flow Problem; Physical Resistance/Sticking
IT WAS REPORTED THAT AN M. BLUE PLUS (#FX824T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVERDRAINAGE AND ADJUSTMENT DIFFICULTIES THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024. 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 20878001 ↗InjuryOct 21, 2024Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT AN M. BLUE PLUS (#FX824T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM SHOWED AN UNDER-DRAINAGE. 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: 2 YEARS, 6 MONTHS WEIGHT: 9 KGS HEIGHT: 80 CM GENDER: MALE.
Patient problems: Hydrocephalus
MAUDE report 20492574 ↗InjurySep 27, 2024Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A M. BLUE PLUS (#FX824T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINANT DEVICE WILL BE RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 6 YEARS, 3 MONTHS HEIGHT: 110 CM WEIGHT: 18 KG GENDER: FEMALE.
Patient problems: Hydrocephalus
MAUDE report 20320897 ↗InjuryAug 27, 2024Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT AN M.BLUE PLUS(#FX824T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM SHOWED AN UNDER-DRAINAGE. 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: 65 YEARS GENDER: MALE.
Patient problems: Hydrocephalus
MAUDE report 20074718 ↗InjuryAug 23, 2024Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem
IT WAS REPORTED THAT AN M.BLUE PLUS(#FX824T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN 2022. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM SHOWED AN OVER-DRAINAGE AND ADJUSTMENT DIFFICULTIES. 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: 2 YEARS, 5 MONTHS WEIGHT: 8 KGS HEIGHT: UNKNOWN. GENDER: FEMALE.
Patient problems: Hydrocephalus
MAUDE report 20048582 ↗InjuryJul 25, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT AN M.BLUE PLUS (#FX824T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM SHOWED ADJUSTMENT DIFFICULTIES. 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: 65 YEARS. WEIGHT: 54 KGS. HEIGHT: 160 CM. GENDER: FEMALE.
Patient problems: Hydrocephalus
MAUDE report 19827676 ↗InjuryJul 3, 2024Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT AN M.BLUE PLUS (#FX824T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM SHOWED AN OVER-DRAINAGE. 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: 41 YEARS. WEIGHT: 60 KGS. HEIGHT: 170 CM. GENDER: MALE.
Patient problems: Hydrocephalus
MAUDE report 19670488 ↗InjuryMar 18, 2024Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A M.BLUE PLUS (#FX824T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN 2023. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM SHOWED AN UNDER-DRAINAGE. 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: 11 MONTHS.
Patient problems: Hydrocephalus
MAUDE report 18925322 ↗InjuryFeb 22, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT A M.BLUE (#FX824T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE VALVE SHOWED ADJUSTMENT DIFFICULTIES. 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: 77 YEARS WEIGHT: 85 KILOGRAMS HEIGHT: 180 CENTIMETER GENDER: UNKNOWN
Patient problems: Hydrocephalus
MAUDE report 18760344 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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