M.BLUE FX846TRecalls & reported problems
Aesculap AG · M.BLUE 5 SYS W/PED.BURRHOLE 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 04041906504762), received between Feb 3, 2023 and Mar 16, 2026 — classified as 4 injuries, 1 malfunction.
The most frequently reported specific device problem is “Mechanical Problem” (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
- Mechanical Problem3
- Infusion or Flow Problem2
- Physical Resistance/Sticking2
Patient problems
- Hydrocephalus5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryMar 16, 2026Infusion or Flow Problem
IT WAS REPORTED THAT AN M. BLUE VALVE (#FX846T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. 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. THE COMPLAINED PRODUCT WAS SENT TO THE MANUFACTURER FOR INVESTIGATION.
Patient problems: Hydrocephalus
MAUDE report 24604172 ↗InjuryMay 2, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT AN M.BLUE SHUNT SYSTEM (#FX846T) SHOWED ADJUSTMENT DIFFICULTIES PREOPERATIVELY. NO PATIENT INVOLMENT. THE COMPLAINED PRODUCT WAS SENT TO THE MANUFACTURER FOR INVESTIGATION.
Patient problems: Hydrocephalus
MAUDE report 21949355 ↗MalfunctionJan 13, 2025Mechanical Problem; Physical Resistance/Sticking; Mechanical Problem; Physical Resistance/Sticking
IT WAS REPORTED THAT A M.BLUE SYSTEM (FX846) WAS NOT ADJUSTABLE. ONLY LIMITED INFORMATION WAS PROVIDED IN THE CUSTOMER COMPLAINT ON THE REGISTRATION FORM. THE RESPONSE TO THE REQUEST FOR FURTHER INFORMATION IS STILL PENDING. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED. THE COMPLAINED PRODUCT WILL BE RETURNED TO THE MANUFACTURER FOR INVESTIGATION.
Patient problems: Hydrocephalus
MAUDE report 21137063 ↗InjuryNov 20, 2023Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT A M.BLUE (#FX846T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM 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: 81 YEARS. HEIGHT: 188 CM. WEIGHT: 77 KG.
Patient problems: Hydrocephalus
MAUDE report 18172808 ↗InjuryFeb 3, 2023Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A M.BLUE (PART # FX846T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN UNDERDRAINAGE AND SHOWED ADJUSTMENT PROBLEMS. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 5 MONTHS, HEIGHT: 67 CENTIMETERS (CM), WEIGHT: 7.39 KILOGRAMS (KG), GENDER: MALE.
Patient problems: Hydrocephalus
MAUDE report 16299944 ↗
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- 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
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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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