M.BLUE PLUS FX834TRecalls & reported problems
Aesculap AG · M.BLUE PLUS SYS W/SPRUNG RESERVOIR · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04041906504854), received between Aug 17, 2022 and Nov 14, 2025 — classified as 4 injuries, 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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
- Insufficient Device Problem Information3
- Leak/Splash1
- Mechanical Problem1
- Obstruction of Flow1
Patient problems
- Hydrocephalus4
- Insufficient Information1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryNov 14, 2025Obstruction of Flow; Obstruction of Flow
THE COMPLAINED PRODUCT WAS SENT TO THE MANUFACTURER AND THE INVESTIGATION HAS BEEN COMPLETED.
Patient problems: Hydrocephalus
MAUDE report 23552708 ↗InjuryNov 7, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE COMPLAINANT THE SHUNT WAS EXPLANTED BECAUSE CEREBROSPINAL FLUID (CSF) WAS ACCUMULATING. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET PROVIDED.
Patient problems: Insufficient Information
MAUDE report 23496104 ↗InjurySep 15, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A M.BLUE PLUS (PART # FX834T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT A SHUNT REPLACEMENT PROCEDURE ON (B)(6) 2022. REPORTEDLY, THE PATIENT WAS EXPERIENCING "CONTINUED SYMPTOMS, HEADACHE, ETC." THE COMPLAINT DEVICE WAS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.
Patient problems: Hydrocephalus
MAUDE report 15432780 ↗InjurySep 15, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A M.BLUE PLUS (PART # FX834T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT A SHUNT REPLACEMENT PROCEDURE ON (B)(6) 2022. REPORTEDLY, THE PATIENT WAS EXPERIENCING "CONTINUED SYMPTOMS, HEADACHE, ETC." THE COMPLAINT DEVICE WAS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.
Patient problems: Hydrocephalus
MAUDE report 15432762 ↗MalfunctionAug 17, 2022Leak/Splash; Mechanical Problem; Leak/Splash; Mechanical Problem
IT WAS REPORTED THAT A M.PLUS PLUS WITH SPRUNG RESERVOIR (PART # FX834T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, POST SURGERY, THE PATIENT HAS DEVELOPED POCKETS OF AIR/GAS IN THE VENTRICLES. THE SURGEON SUSPECTED THE SPRUNG RESERVOIR MIGHT BE THE CAUSE OF THE PROBLEM. THE M.BLUE PLUS WITH SPRUNG RESERVOIR IS STILL IMPLANTED. NO PATIENT DATA AVAILABLE.
Patient problems: Hydrocephalus
MAUDE report 15245660 ↗
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- PROGAV 2.0 FX643TAesculap AG · Shunt, central nervous system and components100 reports
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- M.BLUE PLUS FX804TAesculap AG · Shunt, central nervous system and components82 reports
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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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