REVACLEARRecalls & reported problems across all models

We found 4 models of REVACLEAR by Gambro Dialysatoren GmbH in the FDA's device registry (GUDID). Together they are named in 38 adverse event reports in the FDA's MAUDE database, received between Feb 15, 2018 and Sep 17, 2026 — classified as 10 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (21 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

REVACLEAR recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Nov 23, 2022Open, Classified

   Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak

   Z-0763-2023 · Root cause: Process control · Recall details · FDA record ↗

Most reported REVACLEAR problems

REVACLEAR models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• REVACLEAR Revaclear 400

  Dialyzer, high permeability with or without sealed dialysate system
  1 recall1 report
• Revaclear 400

  Dialyzer, high permeability with or without sealed dialysate system
  24 reports
• Revaclear 300

  Dialyzer, high permeability with or without sealed dialysate system
  10 reports
• REVACLEAR Revaclear 300

  Dialyzer, high permeability with or without sealed dialysate system
  3 reports

Recent REVACLEAR adverse event reports

The 15 most recent reports across all models, 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 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED ON ONE END OF A REVACLEAR 400 DURING HEMODIALYSIS THERAPY. THE TREATMENT WAS DISCONTINUED AND THE EXTRACORPOREAL BLOOD WAS RETURNED TO THE PATIENT. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23042918 ↗
• MalfunctionOct 10, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM ONE END OF A REVACLEAR 400 DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20416852 ↗
• 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 ↗
• MalfunctionSep 20, 2023Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED AN EXTERNAL SALINE SOLUTION LEAK WAS OBSERVED ORIGINATING FROM THE ARTERIAL PORT OF A REVACLEAR 300 SET DURING PRIME. UPON FURTHER INSPECTION, THE PORT WAS NOTED TO BE ¿FRACTURED¿. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17782440 ↗
• MalfunctionAug 7, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED AN EXTERNAL FLUID LEAK WAS OBSERVED ORIGINATING AT THE VENOUS SIDE OF A REVACLEAR 300 SET DURING PRIME. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17477476 ↗
• MalfunctionAug 12, 2022Crack; No Flow

  UPON INITIATION OF DIALYSIS A CRACK WAS NOTED IN DIALYZER. UNABLE TO RETURN BLOOD TO PATIENT. PATIENT LOST APPROXIMATELY 183CC OF BLOOD. DOCTOR WAS AWARE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15216988 ↗
• InjuryMay 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING TREATMENT WITH A POLYFLUX 14L, THE PATIENT EXPERIENCED AN ALLERGIC REACTION AND DECREASING OXYGEN SATURATION. THE PATIENT WAS TREATED WITH 50% OXYGEN (THROUGH A MASK) AND CORTICOSTEROIDS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Hypersensitivity/Allergic reaction; Low Oxygen Saturation

  MAUDE report 14345992 ↗
• InjuryJul 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING TREATMENT WITH A REVACLEAR 400 DIALYZER, THE PATIENT EXPERIENCED AN ALLERGIC REACTION MANIFESTED AS TREMORS, RASH, COUGH, CHEST PAIN, ITCHY THROAT AND DYSPNEA. THE PATIENT WAS TREATED WITH HYDROCORTISONE, A NEBULIZER (NBZ ) AND O2 THROUGH A NASAL CATHETER. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Chest Pain; Cough; Dyspnea; Rash; Shaking/Tremors

  MAUDE report 12151127 ↗
• InjuryJul 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING TREATMENT WITH A REVACLEAR 400 DIALYZER, THE PATIENT EXPERIENCED AN ALLERGIC REACTION MANIFESTED AS TREMORS, RASH, COUGH, CHEST PAIN, ITCHY THROAT AND DYSPNEA. THE PATIENT WAS TREATED WITH HYDROCORTISONE, A NEBULIZER (NBZ ) AND O2 THROUGH A NASAL CATHETER. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Chest Pain; Cough; Dyspnea; Rash; Shaking/Tremors

  MAUDE report 12144128 ↗
• InjuryJul 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING TREATMENT WITH A REVACLEAR DIALYZER, THE PATIENT EXPERIENCED GENERALIZED ANGIOEDEMA, PULMONARY SHUNT, ACUTE LUNG EDEMA, PLANK ABDOMEN WITH IAP MEASURING AT 55 AND "HB" DROPPED TO 4. IT WAS REPORTED THAT SEVERAL INTERVENTION MEASURES WERE PERFORMED TO TRY TO READJUST THE PATIENT'S CLINICAL CONDITION. AN ABDOMINAL APPROACH BY THE GASTRO TEAM AT BEDSIDE WAS PERFORMED WITH AN ATTEMPT AT ABDOMINAL DECOMPRESSION. IT WAS REPORTED THAT THE PATIENTS SYMPTOMS IMPROVED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 12128899 ↗
• MalfunctionMay 19, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED ON A REVACLEAR 400. THE PROCESS STEP WAS UNSPECIFIED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11849106 ↗

Other Gambro Dialysatoren GmbH products

• Polyflux7 models · 47 reports