M.BLUE PLUSRecalls & reported problems across all models
Aesculap AG · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 162
- Deaths reported
- 0
- Injuries reported
- 148
- Recalls
- 0
We found 7 models of M.BLUE PLUS by Aesculap AG in the FDA's device registry (GUDID). Together they are named in 162 adverse event reports in the FDA's MAUDE database, received between Dec 15, 2020 and Jun 8, 2026 — classified as 148 injuries, 14 malfunctions.
The most frequently reported specific device problem is “Infusion or Flow Problem” (83 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported M.BLUE PLUS problems
Device problems
- Infusion or Flow Problem83
- Mechanical Problem40
- Obstruction of Flow40
- Physical Resistance/Sticking31
- Insufficient Device Problem Information9
- Adverse Event Without Identified Device or Use Problem3
- Excess Flow or Over-Infusion3
- Device Misassembled During Manufacturing /Shipping2
Patient problems
- Hydrocephalus151
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions3
- Headache2
- Cyst(s)1
- Discomfort1
- Failure of Implant1
- Implant Pain1
M.BLUE PLUS models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- M.BLUE PLUS FX804TShunt, central nervous system and components82 reports
- M.BLUE PLUS FX824TShunt, central nervous system and components51 reports
- M.BLUE PLUS FX819TShunt, central nervous system and components19 reports
- M.BLUE PLUS FX834TShunt, central nervous system and components5 reports
- M.BLUE PLUS FX844TShunt, central nervous system and components3 reports
- M.BLUE PLUS FX809TShunt, central nervous system and components1 report
- M.BLUE PLUS FX829TShunt, central nervous system and components1 report
Recent M.BLUE PLUS adverse event reports
The 15 most recent reports across all models, 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 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, 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 ↗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 ↗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 ↗InjuryFeb 5, 2026Obstruction of Flow
ACCORDING TO THE EVENT DESCRIPTION AND M.BLUE PLUS SYS W/PED.CONTROL RESERVOIR (PART # FX819T) WAS IMPLANTED APPROXIMATELY 5 MONTHS AGO. REPORTEDLY THE SHUNT HAD BECOME CLOGGED. A REVISION WAS PERFORMED ON (B)(6) 2026. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET PROVIDED.
Patient problems: Hydrocephalus
MAUDE report 24269436 ↗InjuryFeb 2, 2026Obstruction of Flow
IT WAS REPORTED THAT A M.BLUE PLUS (#FX819T) WAS IMPLANTED. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED A BLOCKAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE COMPLAINED PRODUCT WAS NOT YET SENT TO THE MANUFACTURER FOR INVESTIGATION.
Patient problems: Hydrocephalus
MAUDE report 24240433 ↗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 ↗
Other Aesculap AG products
All Aesculap AG devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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