Lixelle S-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 14993478020225), received between Mar 14, 2019 and Oct 17, 2025 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD BEEN RECEIVING LIXELLE S-15 THERAPY SINCE (B)(6) 2025 FOR IMPROVEMENT OF DIALYSIS-RELATED AMYLOIDOSIS SYMPTOMS. TREATMENT WAS PAUSED FOR ONE MONTH IN AUGUST AND RESTARTED IN EARLY (B)(6). ON (B)(6) 2025, APPROXIMATELY 50 MINUTES AFTER RESUMING DIALYSIS WITH LIXELLE, THE PATIENT COMPLAINED OF PALPITATIONS AND FEELING UNWELL, FOLLOWED BY SUDDEN LOSS OF CONSCIOUSNESS AND VOMITING. BLOOD PRESSURE DROPPED FROM 160 MMHG TO 100 MMHG. EMERGENCY INTERVENTION WAS PERFORMED, INCLUDING IMMEDIATE CESSATION OF TREATMENT AND CHEST COMPRESSIONS, WHICH SUCCESSFULLY RESTORED CONSCIOUSNESS. NO HOSPITALIZATION WAS REQUIRED. ON (B)(6) 2025, DIALYSIS WAS PERFORMED WITHOUT LIXELLE AND WAS UNEVENTFUL. THE PATIENT HAS REMAINED STABLE ON I-HDF THERAPY SINCE THEN. THE EVENT WAS **CONSIDERED LIFE-THREATENING** AND REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT. MFR REPORT #: 3002808904-2025-00034.

  Patient problems: Loss of consciousness; Low Blood Pressure/ Hypotension; Vomiting

  MAUDE report 23324356 ↗
• InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT, AN 81-YEAR-OLD FEMALE WITH A HISTORY OF LONG-TERM HEMODIALYSIS, STARTED TREATMENT WITH LIXELLE S-25 ON (B)(6) 2025 FOR DIALYSIS-RELATED AMYLOIDOSIS. ON (B)(6) 2025, HEMOGLOBIN DECREASED TO 6.7 G/DL (PREVIOUS VALUE IN JULY: 13.8 G/DL WITHOUT ESA). THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2025 PRIMARILY FOR BLOOD TRANSFUSION THERAPY AND MONITORING. RBC TRANSFUSIONS WERE ADMINISTERED (2 UNITS ON 08-29 AND 2 UNITS ON 08-30), AND DARBEPOETIN (10 MCG WEEKLY) WAS INITIATED. CONSIDERING THE PATIENT'S PREFERENCE, FURTHER APPLICATION OF LIXELLE IN SUBSEQUENT DIALYSIS SESSIONS WAS DISCONTINUED. HEMOGLOBIN IMPROVED TO 10.7 G/DL BY (B)(6) 2025. THE PHYSICIAN INDICATED A POSSIBLE RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT; RELATIONSHIPS WITH OTHER DEVICES OR DRUGS WERE NOT CONFIRMED. MFR REPORT #: 3002808904-2025-00033.

  Patient problems: Anemia; Fatigue

  MAUDE report 23324328 ↗
• InjuryMar 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LIXELLE S-15 TREATMENT DURING HEMODIALYSIS (HD) WAS INTRODUCED ON (B)(6) 2017 WITHOUT PROBLEMS. LIXELLE S-25, A LARGER SIZE LIXELLE, STARTED TO USE INSTEAD OF S-15 ON (B)(6) 2017 AND WAS USED SUCCESSFULLY. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR ABLATION ON (B)(6) 2018 AND STARTED ADMINISTRATION OF WARFARIN. THE FIRST HD WITHOUT LIXELLE AFTER DISCHARGE ON (B)(6) 2018 WAS PERFORMED. ALTHOUGH THE PATIENT FELT A LITTLE SICK, HOWEVER HE COMPLETED THE HD TO THE END. THE HD WITH LIXELLE S-25 WAS RESUMED ON (B)(6) 2018. THE BLOOD PRESSURE (BP) AT THE START OF TREATMENT WAS ABOUT 150 MMHG BUT DROPPED TO ABOUT 90 MMHG. WHEEZING, BREATHING DIFFICULTY AND PALLOR OF THE FACE WERE OBSERVED. SINCE SPO2 WAS 93%, OXYGEN INHALATION WAS STARTED AT 2 L, HOWEVER THE PATIENT CAUSED NAUSEA AND VOMITING. IT WAS DECIDED THAT THE TREATMENT WAS DISCONTINUED IN 40 MINUTES FROM THE START. HD WITH LIXELLE S-25 WAS CONDUCTED AGAIN ON (B)(6) 2018. THE PATIENT HAD A FEVER OF 38 DEGREES AT THE START. FLU TEST WAS NEGATIVE. AFTER TAKING ANTIPYRETICS, THE TREATMENT WAS STARTED. THE BLOOD PRESSURE WAS 120 MMHG AT THE START OF TREATMENT. ONE HOUR LATER, HE COMPLAINED OF ABDOMINAL DISCOMFORT. ALTHOUGH THE B

  Patient problems: Dyspnea; Fever; Low Blood Pressure/ Hypotension; Vomiting

  MAUDE report 8423409 ↗