M.BLUERecalls & reported problems across all models
Aesculap AG · 18 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 244
- Deaths reported
- 0
- Injuries reported
- 232
- Recalls
- 0
We found 18 models of M.BLUE by Aesculap AG in the FDA's device registry (GUDID). Together they are named in 244 adverse event reports in the FDA's MAUDE database, received between Nov 4, 2020 and Sep 14, 2026 — classified as 232 injuries, 12 malfunctions.
The most frequently reported specific device problem is “Infusion or Flow Problem” (171 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 problems
Device problems
- Infusion or Flow Problem171
- Mechanical Problem90
- Physical Resistance/Sticking37
- Obstruction of Flow32
- Insufficient Device Problem Information12
- Excess Flow or Over-Infusion2
- False Alarm2
- Fitting Problem2
Patient problems
- Hydrocephalus232
- No Clinical Signs, Symptoms or Conditions5
- Failure of Implant4
- Insufficient Information3
- Cancer1
M.BLUE models
18 models, most reported first. Each model has its own page with its reports, recalls and device details.
- M.BLUE FX800TShunt, central nervous system and components62 reports
- M.BLUE FX801TShunt, central nervous system and components52 reports
- M.BLUE FX802TShunt, central nervous system and components45 reports
- M.BLUE FX816TShunt, central nervous system and components28 reports
- M.BLUE FX803TShunt, central nervous system and components18 reports
- M.BLUE FX827TShunt, central nervous system and components6 reports
- M.BLUE FX812TShunt, central nervous system and components5 reports
- M.BLUE FX817TShunt, central nervous system and components5 reports
- M.BLUE FX846TShunt, central nervous system and components5 reports
- M.BLUE FX826TShunt, central nervous system and components4 reports
- M.BLUE FX841TShunt, central nervous system and components4 reports
- M.BLUE FX815TShunt, central nervous system and components3 reports
- M.BLUE FX806TShunt, central nervous system and components2 reports
- M.BLUE FX805TShunt, central nervous system and components1 report
- M.BLUE FX821TShunt, central nervous system and components1 report
- M.BLUE FX837TShunt, central nervous system and components1 report
- M.BLUE FX840TShunt, central nervous system and components1 report
- M.BLUE FX842TShunt, central nervous system and components1 report
Recent M.BLUE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 14, 2026Obstruction of Flow
It was reported that an M.blue Shuntsystem (#FX816T) was implanted on (b)(6) 2024.According to the complainant, the shunt system caused an underdrainage.The patient underwent a revision procedure on (b)(6) 2026.
Patient problems: Hydrocephalus
MAUDE report 50751989 ↗InjuryAug 17, 2026Obstruction of Flow
It was reported that an M.blue Shuntsystem (#FX827T) was implanted.According to the complainant, the shunt system caused a malfunction.The patient underwent a revision procedure.
Patient problems: Hydrocephalus
MAUDE report 50275055 ↗InjuryAug 3, 2026Infusion or Flow Problem
It was reported that an M.blue valve (#FX805T) was implanted on (b)(6) 2026. According to the complainant, the shunt system caused an over-drainage.The patient underwent a revision procedure on (b)(6) 2026. No patient complications were reported as a result of the revision procedure. Related to # 3004721439-2026-00219.
Patient problems: Hydrocephalus
MAUDE report 50118340 ↗InjuryAug 3, 2026Obstruction of Flow; Physical Resistance/Sticking
It was reported that an M. blue (#FX841T) was implanted on (b)(6) 2026. According to the complainant, the valve caused an underdrainage and had adjustment difficulties. The patient underwent a revision procedure on (b)(6) 2026.
Patient problems: Hydrocephalus
MAUDE report 50117609 ↗InjuryJul 27, 2026Infusion or Flow Problem
It was reported that a proGAV 2.0 (#FX673T) was implanted on (b)(6) 2024.According to the complainant, the valve caused an over-drainage.The patient underwent a revision procedure on (b)(6) 2026.No patient complications were reported as a result of the revision procedure.same event as # (b)(6).
Patient problems: Hydrocephalus
MAUDE report 50038832 ↗InjuryJun 23, 2026Obstruction of Flow; Physical Resistance/Sticking
IT WAS REPORTED THAT AN M.BLUE SHUNTSYSTEM (#FX827T) WAS IMPLANTED ON (B)(6) 2025. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM POSSIBLY CAUSED AN UNDERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2026.
Patient problems: Hydrocephalus
MAUDE report 25594425 ↗InjuryMay 22, 2026Obstruction of Flow; Physical Resistance/Sticking
IT WAS REPORTED THAT AN M.BLUE (5) VALVE (#FX801T) WAS IMPLANTED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM/VALVE CAUSED AN UNDERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2026.
Patient problems: Hydrocephalus
MAUDE report 25260520 ↗InjuryMay 18, 2026Obstruction of Flow; Physical Resistance/Sticking
IT WAS REPORTED THAT AN M. BLUE VALVE(#FX802T) WAS IMPLANTED ON (B)(6) 2025. ACCORDING TO THE COMPLAINANT, THE VALVE 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 25200229 ↗InjuryMay 18, 2026Physical Resistance/Sticking
IT WAS REPORTED THAT AN M. BLUE SHUNTSYSTEM (#FX842T) WAS IMPLANTED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS UNABLE TO ADJUST. 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 25200228 ↗InjuryMay 18, 2026Obstruction of Flow
IT WAS REPORTED THAT AN M.BLUE (5) VALVE (#FX801T) WAS IMPLANTED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN UNDERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2026.
Patient problems: Hydrocephalus
MAUDE report 25199925 ↗InjuryMay 12, 2026Obstruction of Flow; Physical Resistance/Sticking
IT WAS REPORTED THAT AN M.BLUE (5) VALVE (#FX801T) WAS IMPLANTED ON (B)(6) 2025. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN UNDERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2026.
Patient problems: Hydrocephalus
MAUDE report 25147998 ↗InjuryMay 4, 2026Infusion or Flow Problem; Physical Resistance/Sticking
IT WAS REPORTED THAT AN M.BLUE VALVE (#FX800T) WAS IMPLANTED. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN OVERDRAINAGE 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 25070497 ↗InjuryApr 20, 2026Infusion or Flow Problem; Physical Resistance/Sticking
IT WAS REPORTED THAT A M. BLUE (#FX802T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN OVERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2026. 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 24927687 ↗MalfunctionApr 20, 2026Physical Resistance/Sticking
IT WAS REPORTED THAT A M.BLUE (#FX802T) WAS NOT ADJUSTABLE BEFORE USE. THE PRODUCT RETURNED IN OPENED STERILE PACKAGING. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE MALFUNCTION. THE SHUNT WAS RETURNED FOR EXAMINATION TO THE MANUFACTURER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24927196 ↗InjuryApr 17, 2026Obstruction of Flow
THIS REPORT IS FILED UNDER AIC REFERENCE XC (B)(4) CC (B)(4). ACCORDING TO THE EVENT DESCRIPTION: MBLUE 0 HAD TO BE REVISED BECUASE IT WAS COMPLETELY OCCLUDED. THE VALVE WAS EXPLANTED AND WAS SHOWN TO HAVE NO FLOW.
Patient problems: Failure of Implant
MAUDE report 24911688 ↗
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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