M.BLUE PLUS FX804TRecalls & reported problems
Aesculap AG · M.BLUE PLUS VALVE · Class 2 · Implant
Quick summary
This Aesculap M.BLUE PLUS shunt valve drains excess fluid from the brain in patients with hydrocephalus. Of its 83 reports, 75 are injuries and 8 are malfunctions, with no deaths. Many describe the shunt draining too little fluid, flow blockages and adjustment difficulties, and many patients needed a revision procedure. 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
- 82
- Deaths reported
- 0
- Injuries reported
- 74
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 04041906504793), received between Dec 15, 2020 and Jun 8, 2026 — classified as 74 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Infusion or Flow Problem” (37 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 Problem37
- Mechanical Problem27
- Obstruction of Flow22
- Physical Resistance/Sticking16
- Excess Flow or Over-Infusion3
- Insufficient Device Problem Information3
- Adverse Event Without Identified Device or Use Problem2
- Device Misassembled During Manufacturing /Shipping2
Patient problems
- Hydrocephalus78
- Insufficient Information2
- Cyst(s)1
- Discomfort1
- Headache1
- Implant Pain1
- Nausea1
Recent adverse event reports
The 25 most recent of 82 reports, in the reporter's own words as published by the FDA.
InjuryJun 8, 2026Obstruction of Flow; Physical Resistance/Sticking
IT WAS REPORTED THAT AN M.BLUE PLUS(#FX804T) WAS IMPLANTED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDER-DRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON (B)(6) 2026. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.
Patient problems: Hydrocephalus
MAUDE report 25430452 ↗InjuryApr 13, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT AN M.BLUE PLUS VALVE (#FX804T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNSPECIFIED DATE. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS NOT WORKING PROPERLY. 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 NOT YET RETURNED TO THE MANUFACTURER FOR EVALUATION. SAME EVENT AS MEDWATCHNO.: 3004721439-2026-00095.
Patient problems: Hydrocephalus
MAUDE report 24862152 ↗MalfunctionMar 23, 2026Obstruction of Flow
IT WAS REPORTED THAT AN M. BLUE PLUS VALVE (#FX804T) WAS TO BE IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2026. ACCORDING TO THE COMPLAINANT, THE VALVE DID NOT DRAIN THE FLUID AFTER BEING IMPLANTED AND WORKING FOR APPROXIMATELY 3 MINUTES. A DIFFERENT SHUNT WAS USED AND THE PROCEDURE RESUMED AS NORMAL. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE PROCEDURE. THE COMPLAINED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: Hydrocephalus
MAUDE report 24662494 ↗InjuryMar 16, 2026Obstruction of Flow
IT WAS REPORTED THAT AN M. BLUE PLUS(#FX804T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2026. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDER-DRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2026. 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 24604467 ↗InjuryMar 2, 2026Obstruction of Flow
IT WAS REPORTED THAT AN M. BLUE PLUS(#FX804T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN (B)(6) 2025. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDER-DRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2026. 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 24482438 ↗InjuryFeb 23, 2026Obstruction of Flow; Physical Resistance/Sticking
IT WAS REPORTED THAT AN M. BLUE PLUS (#FX804T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNSPECIFIED DATE IN (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. 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 24413900 ↗InjuryJan 27, 2026Obstruction of Flow
IT WAS REPORTED THAT AN M.BLUE PLUS (#FX804T) 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 DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. SAME EVENT AS (B)(4).
Patient problems: Hydrocephalus
MAUDE report 24190049 ↗InjuryJan 27, 2026Obstruction of Flow
THE COMPLAINED DEVICE WASRETURNED TO THE MANUFACTURER AND THE INVESTIGATION HAS BEEN COMPLETED.
Patient problems: Hydrocephalus
MAUDE report 24190048 ↗InjuryJan 20, 2026Obstruction of Flow; Physical Resistance/Sticking
IT WAS REPORTED THAT A M.BLUE PLUS(#FX804T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDER-DRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2026. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.
Patient problems: Hydrocephalus
MAUDE report 24115168 ↗InjuryJan 20, 2026Infusion or Flow Problem; Physical Resistance/Sticking
IT WAS REPORTED THAT A M. BLUE PLUS (#FX804T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE SHUNT CAUSED AN OVERDRAINAGE 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 24114838 ↗InjuryDec 29, 2025Infusion or Flow Problem; Physical Resistance/Sticking; Infusion or Flow Problem; Physical Resistance/Sticking
IT WAS REPORTED THAT AN M.BLUE PLUS VALVE (# FX804T) 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 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 23905537 ↗InjuryDec 15, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT AN M.BLUE PLUS VALVE (#FX804T) 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 DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: Hydrocephalus
MAUDE report 23804306 ↗InjuryNov 3, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT A M. BLUE PLUS (# FX804T) WAS IMPLANTED DURING A PROCEDURE ON (B)(6) 2025. ACCORDING TO THE COMPLAINANT, THE VALVE 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 23451863 ↗InjuryNov 3, 2025Obstruction of Flow; Physical Resistance/Sticking; Obstruction of Flow; Physical Resistance/Sticking
IT WAS REPORTED THAT A M.BLUE PLUS (#FX804T) WAS IMPLANTED DURING A PROCEDURE ON (B)(6) 2025. ACCORDING TO THE COMPLAINANT, THE VALVE 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 23451614 ↗InjurySep 10, 2025Obstruction of Flow; Physical Resistance/Sticking; Obstruction of Flow; Physical Resistance/Sticking
IT WAS REPORTED THAT AN M.BLUE PLUS (#FX804T) 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 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 23016896 ↗InjurySep 8, 2025Obstruction of Flow; Physical Resistance/Sticking; Obstruction of Flow; Physical Resistance/Sticking
IT WAS REPORTED THAT A M. BLUE PLUS (#FX804T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. ACCORDING TO THE COMPLAINANT, THE SHUNT CAUSED AN 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 22991084 ↗InjuryAug 18, 2025Obstruction of Flow; Infusion or Flow Problem; Physical Resistance/Sticking; Obstruction of Flow; Infusion or Flow Problem; Physical Resistance/Sticking
IT WAS REPORTED THAT AN M. BLUE PLUS (#FX804T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNSPECIFIED DATE. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE ON AN UNSPECIFIED DATE. 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 22827121 ↗InjuryAug 18, 2025Infusion or Flow Problem; Physical Resistance/Sticking; Infusion or Flow Problem; Physical Resistance/Sticking
IT WAS REPORTED THAT AN M. BLUE PLUS VALVE (#FX804T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNSPECIFIED DATE. 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 22826540 ↗InjuryAug 15, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE COMPLAINANT THE SHUNT HAD TO BE EXPLANTED BECAUSE THE VALVE COULDN'T BE REPROGRAMMED. REPORTEDLY THE LOCKING MECHANISM WOULD NOT ACTIVATE TO RELEASE THE BREAK. A NEW SHUNT SYSTEM WAS IMPLANTED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 22814608 ↗InjuryAug 4, 2025Obstruction of Flow; Physical Resistance/Sticking; Obstruction of Flow; Physical Resistance/Sticking
IT WAS REPORTED THAT A M. BLUE PLUS (#FX804T) WAS IMPLANTED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN 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 22698166 ↗InjuryJul 3, 2025Infusion or Flow Problem; Physical Resistance/Sticking; Infusion or Flow Problem; Physical Resistance/Sticking
IT WAS REPORTED THAT AN M.BLUE PLUS VALVE (FX804T) 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.
Patient problems: Hydrocephalus
MAUDE report 22394332 ↗InjuryJul 3, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT AN M. BLUE PLUS (#FX804T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNSPECIFIED DATE IN 2020. 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 DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: Hydrocephalus
MAUDE report 22394159 ↗InjuryJun 23, 2025Obstruction of Flow; Physical Resistance/Sticking; Obstruction of Flow; Physical Resistance/Sticking
IT WAS REPORTED THAT AN M. BLUE PLUS(#FX804T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN BLOCKAGE 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.
Patient problems: Hydrocephalus
MAUDE report 22309052 ↗InjuryJun 23, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT A M. BLUE PLUS (#FX804T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, TH ESHUNT SYSTEM CAUSED AN UNDER DRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2025. THE COMPLAINED PRODUCT WAS RETURNED FOR EXAMINATION TO THE MANUFACTURER. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.
Patient problems: Cyst(s)
MAUDE report 22308938 ↗InjuryMay 30, 2025Excess Flow or Over-Infusion; Physical Resistance/Sticking; Excess Flow or Over-Infusion; Physical Resistance/Sticking
THE COMPLAINED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION HAS BEEN COMPLETED.
Patient problems: Hydrocephalus
MAUDE report 22117136 ↗
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- PROGAV 2.0 FX643TAesculap AG · Shunt, central nervous system and components100 reports
- Becker® 46128Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 recall50 reports
- proSA® FV701TChristoph Miethke GmbH & Co. KG · Shunt, central nervous system and components82 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.