M.BLUE FX800TRecalls & reported problems
Aesculap AG · M.BLUE 0 VALVE · Class 2 · Implant
Quick summary
This Aesculap M.Blue 0 valve (FX800T) is an adjustable valve implanted in the brain to drain fluid in patients with hydrocephalus. The 61 reports mostly describe drainage that runs too fast or too slow, valves that stick or are hard to adjust, and valves that block flow entirely, in patients with hydrocephalus; 53 reports involved injuries, 8 malfunctions, and no deaths. No recalls name this device. Reports fell from 11 in the earlier 12 months to 7 in the most recent.
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
- 62
- Deaths reported
- 0
- Injuries reported
- 54
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 04041906504397), received between May 7, 2021 and Jul 27, 2026 — classified as 54 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Infusion or Flow Problem” (41 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 Problem41
- Mechanical Problem19
- Insufficient Device Problem Information9
- Obstruction of Flow8
- Physical Resistance/Sticking5
- False Alarm2
- Excess Flow or Over-Infusion1
- Patient Device Interaction Problem1
Patient problems
- Hydrocephalus55
- Failure of Implant4
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 25 most recent of 62 reports, in the reporter's own words as published by the FDA.
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 ↗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 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 ↗InjuryMar 23, 2026Obstruction of Flow; Physical Resistance/Sticking
IT WAS REPORTED THAT AN M.BLUE VALVE (#FX800T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. 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.
Patient problems: Hydrocephalus
MAUDE report 24662610 ↗InjuryMar 9, 2026Infusion or Flow Problem
IT WAS REPORTED THAT AN M. BLUE (0) (#FX800T) WAS IMPLANTED TOGETHER WITH A PROGAV 2.0 DURING A PROCEDURE PERFORMED ON (B)(6) 2025. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN OVERDRAINAGE. 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 24546191 ↗InjuryJan 30, 2026Obstruction of Flow
IT WAS REPORTED THAT AN M.BLUE 0 VALVE (#FX800T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. 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 MEDWATCH NO.: 3004721439-2026-00004.
Patient problems: Hydrocephalus
MAUDE report 24221938 ↗InjuryJan 23, 2026Patient Device Interaction Problem
IT WAS REPORTED TO AESCULAP INC. THAT A M. BLUE 0 VALVE (PART # FX800T) WAS IMPLANTED ON AN UNSPECIFIED DATE. ACCORDING TO THE COMPLAINANT, THE DEVICE WAS EXPLANTED ON (B)(6) 2025 FOR AN UNSPECIFIED REASON. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.
Patient problems: Hydrocephalus
MAUDE report 24165250 ↗InjuryNov 3, 2025Infusion or Flow Problem; Insufficient Device Problem Information; Physical Resistance/Sticking; Infusion or Flow Problem; Insufficient Device Problem Information; Physical Resistance/Sticking
IT WAS REPORTED THAT A M. BLUE 0 VALVE (#FX800T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN OVER-DRAINAGE AND HAD ADJUSTMEN 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 NOW RETURNED TO THE MANUFACTURER FOR EVALUATION. SAME EVENT AS #3004721439-2025-00361.
Patient problems: Hydrocephalus
MAUDE report 23451064 ↗InjuryAug 11, 2025Obstruction of Flow; Physical Resistance/Sticking; Obstruction of Flow; Physical Resistance/Sticking
IT WAS REPORTED THAT A M.BLUE (#FX800T) WAS IMPLANTED TOGETHER WITH A PROGAV 2.0 (#FX424T) DURING A PROCEDURE PERFORMED 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) 2025. THE COMPLAINED PRODUCT WAS SENT TO THE MANUFACTURER FOR INVESTIGATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. SAME INCIDENT AS MEDWATCH#3004721439-2025-00229.
Patient problems: Hydrocephalus
MAUDE report 22773457 ↗InjuryMay 29, 2025Obstruction of Flow; Insufficient Device Problem Information; Obstruction of Flow; Insufficient Device Problem Information
THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4). IT WAS REPORTED THAT AN M. BLUE (#FX800T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNSPECIFIED DATE. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON AN UNSPECIFIED DATE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.
Patient problems: Hydrocephalus
MAUDE report 22104776 ↗InjuryMay 20, 2025Obstruction of Flow; Insufficient Device Problem Information; Obstruction of Flow; Insufficient Device Problem Information
IT WAS REPORTED THAT AN M. BLUE (#FX800T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNSPECIFIED DATE. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE. 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 NOT YET RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: Hydrocephalus
MAUDE report 22051987 ↗InjuryApr 21, 2025Insufficient Device Problem Information; Physical Resistance/Sticking; Insufficient Device Problem Information; Physical Resistance/Sticking
THE COMPLAINED PRODUCT WAS SENT TO THE MANUFACTURER FOR INVESTIGATION.
Patient problems: Hydrocephalus
MAUDE report 21875771 ↗InjuryApr 14, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT A M.BLUE (#FX800T) WAS IMPLANTED TOGETHER WITH A PROGAV 2.0 AND A SHUNTASSISTANT 2.0 DURING A PROCEDURE PERFORMED 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. THE RELEASE FOR EXAMINATION HAS NOT YET BEEN SUBMITTED. FOR THIS REASON, AN EXAMINATION IS STILL PENDING. SAME INCIDENT AS MEDWATCH# 3004721439-2025-00107 AND #3004721439-2025-00108.
Patient problems: Hydrocephalus
MAUDE report 21833711 ↗InjuryApr 11, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE EVENT DESCRIPTION THERE WERE TWO FAILED SHUNTS WITHIN THE LAST TWO MONTHS. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4).
Patient problems: Failure of Implant
MAUDE report 21824545 ↗InjuryMar 18, 2025Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT AN M. BLUE (#FX800T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE VALVE 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 PRODUCT WAS SENT TO THE MANUFACTURER FOR INVESTIGATION. SAME EVENT AS #: 3004721439-2025-00066.
Patient problems: Hydrocephalus
MAUDE report 21631482 ↗InjuryMar 10, 2025Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A M.BLUE (#FX800T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN 2022. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN OVERDRAINAGE. 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. THE PACKAGE WAS ONLY DELIVERED TO US TODAY BECAUSE IT WAS LOST IN THE MAIL. NOW IT HAS BEEN FOUND AND DELIVERED TO US. SAME EVENT AS #3004721439-2025-00071.
Patient problems: Hydrocephalus
MAUDE report 21558806 ↗InjuryFeb 27, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT AN M. BLUE (0) VALVE (#FX800T) WAS IMPLANTED ON (B)(6) 2025. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN UNDER-DRAINAGE. 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: Failure of Implant
MAUDE report 21483124 ↗MalfunctionFeb 21, 2025False Alarm; False Alarm
AS REPORTED BY THE USER FACILITY: BIOMED TECH REPORTED UNIT TO HAVE DOWNSTREAM OCCLUSION HIGH PRESSURE BUT NOTHING LOOKED TO BE WRONG WITH LINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21439870 ↗MalfunctionFeb 21, 2025False Alarm; False Alarm
AS REPORTED BY THE USER FACILITY: BIOMED TECH REPORTED UNIT TO HAVE DOWNSTREAM OCCLUSION HIGH PRESSURE BUT NOTHING LOOKED TO BE WRONG WITH LINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21438047 ↗InjuryOct 30, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
ACCORDING TO THE EVENT DESCRIPTION: AN M-BLUE PLUS (PART# FX800T) WAS SET AT 11(PG2) AND 13(MB) AND HAS BEEN ADJUSTED UP AND DOWN BUT WAS CONTINUOUSLY EXPERIENCING OVER DRAINAGE. REPORTEDLY THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024.
Patient problems: Failure of Implant
MAUDE report 20571227 ↗InjuryOct 11, 2024Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem
IT WAS REPORTED THAT AN M.BLUE VALVE WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE VALVE SHOWED AN UNDER-DRAINAGE AND ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON (B)(6) 2024. THE COMPLAINANT DEVICE HAS NOT YET RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. GENDER: FEMALE.
Patient problems: Hydrocephalus
MAUDE report 20426845 ↗InjurySep 16, 2024Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A M.BLUE (#FX800T) CAUSED AN OVERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINANT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 11 YEARS HEIGHT: 155 CM WEIGHT: 45 KG GENDER: UNKNOWN SAME EVENT/PATIENT AS (B)(6).
Patient problems: Hydrocephalus
MAUDE report 20224861 ↗InjuryAug 27, 2024Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A M. BLUE (#FX800T) 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. THE COMPLAINANT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 6 YEARS GENDER: FEMALE.
Patient problems: Hydrocephalus
MAUDE report 20074686 ↗InjuryJun 26, 2024Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A M. BLUE (#FX800T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023 (NOT CONSISTENT WITH THE PRODUCTION DATE). ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN OVERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINANT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 15 YEARS, 9 MONTHS. HEIGHT: 175 CM. WEIGHT: 75 KG. GENDER: MALE.
Patient problems: Hydrocephalus
MAUDE report 19613784 ↗InjuryMay 8, 2024Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem
IT WAS REPORTED THAT AN M.BLUE (#FX800T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN OVERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINANT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 21 YEARS GENDER: FEMALE
Patient problems: Hydrocephalus
MAUDE report 19267426 ↗
Other Shunt, central nervous system and components devices
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- Exacta™ 46700Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 recall2 deaths163 reports
- Strata® 42866Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 death160 reports
- proGAV 2.0® FX410TChristoph Miethke GmbH & Co. KG · Shunt, central nervous system and components119 reports
- 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
- M.BLUE PLUS FX804TAesculap AG · Shunt, central nervous system and components82 reports
- proSA® FV701TChristoph Miethke GmbH & Co. KG · Shunt, central nervous system and components82 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.