M.BLUE PLUS FX819TRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 04041906504823), received between Jan 4, 2023 and Feb 5, 2026 — classified as 18 injuries, 1 malfunction.

The most frequently reported specific device problem is “Obstruction of Flow” (9 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryNov 20, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT AN M.BLUE PLUS (#FX819T) 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. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.

  Patient problems: Hydrocephalus

  MAUDE report 23608514 ↗
• InjuryOct 15, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT AN M.BLUE PLUS(#FX819T) 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 PRODUCT WAS SENT TO THE MANUFACTURER FOR INVESTIGATION.

  Patient problems: Hydrocephalus

  MAUDE report 23277739 ↗
• InjuryAug 4, 2025Obstruction of Flow; Physical Resistance/Sticking; Obstruction of Flow; Physical Resistance/Sticking

  IT WAS REPORTED THAT A M.BLUE PLUS (#FX819T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES (SELF ADJUSTMENT). 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: Hydrocephalus

  MAUDE report 22698137 ↗
• InjuryJul 21, 2025Obstruction of Flow; Physical Resistance/Sticking; Obstruction of Flow; Physical Resistance/Sticking

  IT WAS REPORTED THAT AN M.BLUE PLUS (# FX819T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (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) 2025. 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 22554144 ↗
• InjuryJun 23, 2025Obstruction of Flow; Physical Resistance/Sticking; Obstruction of Flow; Physical Resistance/Sticking

  IT WAS REPORTED THAT AN M. BLUE PLUS (#FX819T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE AND HAB ADJUSTMENT 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 PRODUCT WAS SENT TO THE MANUFACTURER FOR INVESTIGATION.

  Patient problems: Hydrocephalus

  MAUDE report 22309279 ↗
• InjuryJun 23, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT AN M. BLUE PLUS (#FX819T) 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 PRODUCT WAS SENT TO THE MANUFACTURER FOR INVESTIGATION.

  Patient problems: Hydrocephalus

  MAUDE report 22309209 ↗
• InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A M. BLUE PLUS (#FX819T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. THE PATIENT WAS READMITTED BACK INTO THE HOSPITAL ON (B)(6) 2025 WITH HEADACHE, RHINORRHEA AND SCALP BOGGINESS. THE REPROGRAMMED SHUNT AFTER PATIENT WAS READMITTED AND RECEIVED MINIMAL CHANGE IN THE PATIENT'S CONDITION. THE PATIENT WENT IN FOR A SCAN ON (B)(6) 2025 TO EVALUATE THE SHUNT BUT THEY ALSO SETUP AN OR TIME FOR (B)(6) 2025 TO POTENTIALLY REPLACE THE SHUNT SYSTEM. SCANS CAME BACK (B)(6) 2025 AND WAS DETERMINED THAT THERE MIGHT BE A LEAK AROUND THE VENTRICULAR CATHETER. THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2025. DURING THE SURGERY, NO LEAK FROM THE VENTRICULAR CATHETER AND THEN DETERMINED, IT MAY BE COMING FROM THE PERIOTONEAL CATHETER BUT FOUND NO LEAK THERE AS WELL. THE SURGEON DECIDED TO CHANGE OUT THE ENTIRE FX819T. A NEW FX819T WAS IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. NO SAMPLE FOR EXAMINATION. THE SAMPLE HAD ALREADY BEEN DISCARDED AT THE HOSPITAL.

  Patient problems: Hydrocephalus

  MAUDE report 21746533 ↗
• InjuryApr 1, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED TO AESCULAP INC. THAT A M. BLUE PLUS SYS W/PED. CONTROL RESERVOIR (PART# FX819T) WAS IMPLANTED ON (B)(6)2025. ACCORDING TO THE COMPLAINT DESCRIPTION THE PATIENT WAS FINE AND THEN WAS READMITTED BACK INTO THE HOSPITAL ON (B)(6) 2025 WITH HEADACHE, RHINORRHEA AND SCALP BOGGINESS. THE PHYSICIAN REPROGRAMMED SHUNT AFTER PATIENT WAS READMITTED AND RECEIVED MINIMAL CHANGE IN THE PATIENT'S CONDITION. THE PATIENT WENT IN FOR A SCAN ON (B)(6) 2025 TO EVALUATE THE SHUNT BUT THEY ALSO SETUP AN OR TIME FOR (B)(6) 2025 TO POTENTIALLY REPLACE THE SHUNT SYSTEM. SCANS CAME BACK (B)(6) 2025 AND WAS DETERMINED THAT THERE MIGHT BE A LEAK AROUND THE VENTRICULAR CATHETER. THE PATIENT WAS REVISED ON (B)(6) 2025. DURING THE SURGERY, THEY FOUND NO LEAK FROM THE VENTRICULAR CATHETER AND THEN DETERMINED, IT MAY BE COMING FROM THE PERITONEAL CATHETER, BUT FOUND NO LEAK THERE AS WELL. THE SURGEON DECIDED TO CHANGE OUT THE ENTIRE FX819T. THEY EXPLANTED THE ORIGINAL FX819T AND THE WAS PATIENT IMPLANTED WITH NEW FX819T WITH SETTINGS OF 6 AND 20 AGAIN. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. NO SAMPLE FOR EXAMINATION. THE SAMPLE HAD ALREADY BEEN DISCARDED AT T

  Patient problems: Headache

  MAUDE report 21746530 ↗
• InjuryJan 13, 2025Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT AN M. BLUE PLUS SHUNTSYSTEM (#FX819T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM 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 DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hydrocephalus

  MAUDE report 21136808 ↗
• InjuryDec 9, 2024Obstruction of Flow; Physical Resistance/Sticking; Obstruction of Flow; Physical Resistance/Sticking

  IT WAS REPORTED THAT AN M.BLUE PLUS (#FX819T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024. 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 20878444 ↗
• InjurySep 16, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT AN M.BLUE PLUS (#FX819T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) /2024. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVERDRAINAGE AND AN UNDERDRAINAGE. 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: 34 YEARS HEIGHT: 170 CM WEIGHT: 70 KG GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 20225205 ↗
• InjuryMay 28, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A M.BLUE PLUS SYSTEM (#FX819T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE. 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: 4 YEARS, 2 MONTHS WEIGHT: 11 KG HEIGHT: 87.3 CM GENDER: MALE.

  Patient problems: Hydrocephalus

  MAUDE report 19404342 ↗
• InjuryApr 4, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A M.BLUE PLUS (#FX819T) WILL BE IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE SYSTEM CAUSED AN OVERDRAINAGE/UNDERDRAIANGE AND COULD NOT BE IMPLANTED. THE COMPLAINANT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE PROCEDURE. AGE: 10 YEARS WEIGHT: 19.4 KG GENDER: MALE

  Patient problems: Hydrocephalus

  MAUDE report 19044567 ↗
• MalfunctionJan 2, 2024Wrong Label; Wrong Label

  IT HAS BEEN REPORTED THAT THE LABEL ON THE BACK OF AN M.BLUS PLUS BOX (#FX819T) WAS NOT LABELED WITH THE CORRECT SERIAL NUMBER. THE SERIAL NUMBER MATCHES THE OTHER SHIPPED PRODUCT. THE QR CODE AND THE LABEL ON THE PRODUCT ARE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18425550 ↗
• InjurySep 12, 2023Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A M.BLUE PLUS (#FX819T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE SHUNT SHOWED A MALFUCTION. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON (B)(6) 2023. THE COMPLAINANT DEVICE HAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 72 YEARS. WEIGHT: 68 KILOGRAMS. HEIGHT: 178 CENTIMETERS. GENDER: UNKNOWN.

  Patient problems: Hydrocephalus

  MAUDE report 17731612 ↗
• InjuryMay 17, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A M.BLUE PLUS (#FX819T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM SHOWED NO DRAINAGE IMMEDIATELY AFTER IMPLANTATION. THE PRODUCT WAS REMOVED AND A REPLACEMENT PRODUCT WAS USED. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 1 YEAR; WEIGHT: 10 KILOGRAMS (KG); GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 16950488 ↗
• InjuryJan 4, 2023Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A M.BLUE PLUS (#FX819T) 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 HAD ADJUSTMENT DIFFCULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED 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.

  Patient problems: Hydrocephalus

  MAUDE report 16098755 ↗