Revaclear 300 (REF 114745)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07332414114916), received between Feb 15, 2018 and Sep 17, 2026 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Calcified

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50808965 ↗
• InjuryDec 29, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING TREATMENT WITH TWO REVACLEAR 300 DIALYZERS, BLOOD WAS OBSERVED IN THE DIALYSATE. IT WAS REPORTED THE BLOOD COULD NOT BE RETURNED TO THE PATIENT. THE PATIENT RECEIVED A BLOOD TRANSFUSION. ACCORDING TO THE REPORTER, ¿URGENT DIALYSIS¿ WAS ALSO PERFORMED. THE ESTIMATED VOLUME OF BLOOD LOSS WAS 560ML. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23912000 ↗
• MalfunctionDec 23, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM A "BROKEN PART" OF A REVACLEAR 300 DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23878916 ↗
• MalfunctionSep 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING TREATMENT WITH A REVACLEAR 300 DIALYZER, THE PATIENT EXPERIENCED HEARTBURN, BELCHING, AND INCREASED BLOOD PRESSURE. AFTER TREATMENT WAS COMPLETED THE PATIENT EXPERIENCED HEMOLYSIS, PRESSURE IN THE STOMACH, AND BLOOD IN THE URINE. IT WAS ALSO REPORTED THAT THE PATIENT HAD ISSUES WITH COAGULATIONS THAT RESULTED IN INCREASED DOSES OF INNOHEP (AD. 8000 IU). IT WAS REPORTED THE DIALYZER WAS NOT REUSED. NO OTHER PRODUCT ISSUES WERE OBSERVED. FOR TWO DAYS THE PATIENT WAS TREATED IN THE CARDIOLOGY WARD AND THEN WAS IN DOMICILIARY CARE. THE PATIENT HAD DIALYSIS WITH A NON-BAXTER DIALYZER IN THE HOSPITAL AND WAS TREATED WITH NON-BAXTER EQUIPMENT IN INPATIENT CARE. NO FURTHER ISSUES WERE NOTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Abdominal Distention; Eructate; Heartburn/Indigestion; Hematuria; Hemolysis; High Blood Pressure/ Hypertension

  MAUDE report 20176459 ↗
• MalfunctionSep 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING TREATMENT WITH A REVA CLEAR 300 DIALYZER, THE PATIENT EXPERIENCED SEVERE ABDOMINAL PAIN AND INCREASED BLOOD PRESSURE. THE TREATMENT WAS STOPPED AT AN UNKNOWN STAGE. AFTER TREATMENT THE PATIENT EXPERIENCED HEMOLYSIS AND BLOOD IN THE URINE. THE DIALYZER WAS NOT REUSED AND NO OTHER PRODUCT DEFECTS WERE OBSERVED. TREATMENT FOR THE EVENTS WERE NOT REPORTED. FOR FOUR DAYS THE PATIENT WAS BRIEFLY TREATED IN THE INTERMEDIATE CARE UNIT AND WAS IN DOMICILIARY CARE. THE PATIENT UNDERWENT DIALYSIS WITH A NON-BAXTER DIALYZER IN THE HOSPITAL AND WAS TREATED WITH NON-BAXTER EQUIPMENT IN INPATIENT CARE. NO FURTHER ISSUES WERE NOTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Abdominal Pain; Hematuria; Hemolysis; High Blood Pressure/ Hypertension

  MAUDE report 20170127 ↗
• InjuryJan 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY THREE HOURS INTO TREATMENT WITH A REVACLEAR 300 DIALYZER, A PATIENT EXPERIENCED A SUDDEN SYMPTOMATIC HAEMOLYSIS REPORTED AS DARK URINE, ABDOMINAL PAIN, CLAMMINESS AND DIARRHEA. THE PATIENT WAS TREATED WITH GAVISCON 15 ML, PANTOPRAZOLE 40 MG INTRAVENOUSLY AND LITALGIN 10MG/ML INTRAVENOUSLY. TREATMENT WAS TERMINATED WITH BLOOD RETURN, AND THE PATIENT RETURNED HOME. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL THE "NEXT DAY" AND WAS DIAGNOSED WITH HEMOLYSIS AND WAS HOSPITALIZED. NO MEDICAL INTERVENTION DURING THE HOSPITALIZATION WAS REPORTED. AT THE TIME OF THIS REPORT, THE PATIENT WAS REPORTED TO HAVE RECOVERED AND ¿BACK TO PREVIOUS CONDITION¿. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Abdominal Pain; Diarrhea; Hemolysis; Sweating

  MAUDE report 8249978 ↗
• InjuryDec 13, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED A HEMODIALYSIS PATIENT WAS THREE MINUTES INTO TREATMENT WITH A REVACLEAR 300 DIALYZER WHEN A TMP ALARM WAS GENERATED BY THE MACHINE. AFTER OBSERVATION, PARTICLES WERE OBSERVED IN THE DIALYZER. THE PATIENT WAS DISCONNECTED FROM THE SET. IT WAS REPORTED THE PATIENT EXPERIENCED A HEADACHE AND HIGH BLOOD PRESSURE. THE PATIENT RECEIVED AN UNSPECIFIED MEDICATION FOR THE HIGH BLOOD PRESSURE. TREATMENT FOR THE HEADACHE WAS NOT REPORTED. AFTER THE TREATMENTS, THE BLOOD PRESSURE WAS STABILIZED AND THE PATIENT WAS RE-DIALYZED IN ANOTHER DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Headache; High Blood Pressure/ Hypertension

  MAUDE report 8159907 ↗
• MalfunctionAug 30, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT REVACLEAR 300 HAD AN EXTERNAL SOLUTION LEAKAGE DURING PATIENT TREATMENT. IT WAS IDENTIFIED THAT ONE OF THE DIALYSATE PORTS WAS BROKEN RESULTING IN AN EXTERNAL SOLUTION LEAKAGE. THE BLOOD WAS RETURNED AND THE FILTER WAS REPLACED. NO BLOOD LOSS WAS REPORTED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7834071 ↗
• MalfunctionMar 26, 2018Device Contamination with Chemical or Other Material

  REVACLEAR DIALYZER HAD BLACK SPOTS FLOATING IN THE CHAMBER.

  Patient problems: No Information

  MAUDE report 7369414 ↗
• MalfunctionFeb 15, 2018Complete Blockage; Fluid/Blood Leak; Device Displays Incorrect Message

  DIALYSIS INITIATED WITH NO PROBLEMS. RAN FOR 20 MINUTES AND BLOOD CLOTTED IN THE DIALYZER AND VENOUS CHAMBER. BLOOD RETURNED NEW SET UP ON THE MACHINE. AGAIN DIALYSIS RESUMED WITH NO PROBLEMS WITH PATIENT OR MACHINE. TWENTY FIVE MINUTES INTO TREATMENT VENOUS PRESSURE ALARM ON MACHINE ALARMED. VENOUS PRESSURE WAS AT 300. FLUSHED LINES AND VENOUS PRESSURES DECREASED THE SUDDENLY INCREASED TO 840. AT THE SAME TIME A BLOOD LEAK ALARM OCCURRED. VISIBLE BLOOD NOTED IN THE VENOUS (BLUE) DIALYSATE LINE. BLOOD NOT RETURNED.

  Patient problems: No Code Available

  MAUDE report 7273057 ↗