LIXELLE S-15 (REF N/A)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 14993478010059), received between Aug 12, 2025 and Aug 20, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Biocompatibility” (2 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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 20, 2025Device Appears to Trigger Rejection; Biocompatibility; Lack of Effect; Device Appears to Trigger Rejection; Biocompatibility; Lack of Effect

  AS AN IMPORTER, WE ARE REQUIRED TO REPORT PER 21CFR803.40(A). MFR MDR#3002808904-2025-00029 ON (B)(6) 2025, A 52-YEAR-OLD FEMALE PATIENT UNDERGOING ONLINE HDF THERAPY WITH THE LIXELLE S-15 COLUMN FOR DIALYSIS-RELATED AMYLOIDOSIS DEVELOPED SYMPTOMS CONSISTENT WITH AN ANAPHYLAXIS-LIKE REACTION. AT APPROXIMATELY 14:17, SHE EXPERIENCED ITCHING ON HER PALMS AND SOLES, FOLLOWED BY REDNESS IN HER RIGHT UPPER LIMB. BY 14:54, SHE DEVELOPED WIDESPREAD RASH AND SEVERE ITCHING, PROMPTING IMMEDIATE DISCONTINUATION OF DIALYSIS. THE RASH PROGRESSED TO URTICARIA, AND THE PATIENT WAS URGENTLY TRANSFERRED TO (B)(6) HOSPITAL. UPON ARRIVAL, ITCHING HAD IMPROVED, BUT ELEVATED BLOOD PRESSURE AND HEADACHE PERSISTED. EPINEPHRINE (EPIPEN) WAS ADMINISTERED, ALTHOUGH LATER DETERMINED TO BE CONTRAINDICATED FOR THIS PATIENT DUE TO HER KNOWN ALLERGY PROFILE. SHE WAS HOSPITALIZED FOR ONE NIGHT AND DISCHARGED THE FOLLOWING DAY. ON (B)(6), A PHYSICIAN DIAGNOSED THE EVENT AS LIKELY ANAPHYLAXIS. THE PATIENT HAS A COMPLEX MEDICAL HISTORY INCLUDING DIABETES-RELATED NEPHROPATHY, RENAL SCLEROSIS, CONGENITAL RENAL AGENESIS, AND DIALYSIS-RELATED AMYLOIDOSIS. SHE HAS MULTIPLE DRUG ALLERGIES AND HAD BEEN RECEIVING UPASITA F

  Patient problems: Anaphylactoid / Anaphylaxis; Erythema; Headache; High Blood Pressure/ Hypertension; Itching Sensation; Urticaria

  MAUDE report 22848881 ↗
• InjuryAug 12, 2025Device Appears to Trigger Rejection; Biocompatibility; Lack of Effect; Device Appears to Trigger Rejection; Biocompatibility; Lack of Effect

  ON (B)(6) 2025, A 52-YEAR-OLD FEMALE PATIENT UNDERGOING ONLINE HDF THERAPY WITH THE LIXELLE S-15 COLUMN FOR DIALYSIS-RELATED AMYLOIDOSIS DEVELOPED SYMPTOMS CONSISTENT WITH AN ANAPHYLAXIS-LIKE REACTION. AT APPROXIMATELY 14:17, SHE EXPERIENCED ITCHING ON HER PALMS AND SOLES, FOLLOWED BY REDNESS IN HER RIGHT UPPER LIMB. BY 14:54, SHE DEVELOPED WIDESPREAD RASH AND SEVERE ITCHING, PROMPTING IMMEDIATE DISCONTINUATION OF DIALYSIS. THE RASH PROGRESSED TO URTICARIA, AND THE PATIENT WAS URGENTLY TRANSFERRED TO (B)(6) HOSPITAL. UPON ARRIVAL, ITCHING HAD IMPROVED, BUT ELEVATED BLOOD PRESSURE AND HEADACHE PERSISTED. EPINEPHRINE (EPIPEN) WAS ADMINISTERED, ALTHOUGH LATER DETERMINED TO BE CONTRAINDICATED FOR THIS PATIENT DUE TO HER KNOWN ALLERGY PROFILE. SHE WAS HOSPITALIZED FOR ONE NIGHT AND DISCHARGED THE FOLLOWING DAY. ON (B)(6) A PHYSICIAN DIAGNOSED THE EVENT AS LIKELY ANAPHYLAXIS. THE PATIENT HAS A COMPLEX MEDICAL HISTORY INCLUDING DIABETES-RELATED NEPHROPATHY, RENAL SCLEROSIS, CONGENITAL RENAL AGENESIS, AND DIALYSIS-RELATED AMYLOIDOSIS. SHE HAS MULTIPLE DRUG ALLERGIES AND HAD BEEN RECEIVING UPASITA FOR APPROXIMATELY ONE YEAR. WHILE THE EXACT CAUSE OF THE REACTION REMAINS UNCLEAR, THE LIXELLE

  Patient problems: Anaphylactoid / Anaphylaxis; Erythema; Headache; High Blood Pressure/ Hypertension; Itching Sensation; Urticaria

  MAUDE report 22780430 ↗