Revaclear 400 (REF 114746)Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 07332414114923), received between Mar 26, 2018 and Sep 12, 2025 — classified as 7 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (14 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionNov 12, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AN EXTERNAL BLOOD LEAK WAS OBSERVED ON A REVACLEAR 400 DIALYZER DURING TREATMENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10830863 ↗
• InjuryAug 17, 2020Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT A PATIENT BEING TREATED WITH ONE (1) UNIT OF REVACLEAR 400 DIALYZER, EXPERIENCED ¿PROBLEMS RELATED TO THE FLOW OF THE DIALYZER OCCURRED, WITH THE LOSS OF THE ENTIRE SYSTEM DUE TO THE RUPTURE AND CONSEQUENT LOSS OF BLOOD.¿ THE AMOUNT OF BLOOD LOSS WAS NOT REPORTED. IT WAS REPORTED THE PATIENT RECEIVED A BAG OF PACKED RED BLOOD CELLS. THE PATIENT OUTCOME WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Blood Loss

  MAUDE report 10416738 ↗
• MalfunctionSep 18, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED DURING PATIENT TREATMENT WITH A REVACLEAR 400 DIALYZER, AN INTERNAL BLOOD LEAK WAS OBSERVED. TREATMENT WAS DISCONTINUED WITHOUT RETURNING THE EXTRACORPOREAL BLOOD TO THE PATIENT. THE DIALYZER WAS REPLACED, AND A NEW TREATMENT WAS INITIATED. IT WAS REPORTED ANOTHER INTERNAL BLOOD LEAK WAS OBSERVED. IT WAS REPORTED THE BLOOD LOSS WAS ¿AROUND 500ML¿ (250 ML FROM EACH DIALYZER AND CIRCUIT). THERE WAS NO REPORT OF PATIENT SYMPTOM, INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9081792 ↗
• MalfunctionSep 9, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING TREATMENT WITH REVACLEAR 400 SET, TWO INTERNAL BLOOD LEAKS WAS OBSERVED. BLOOD LEAK DETECTION ALARMS WERE GENERATED BY THE MACHINE WHILE THE PATIENT WAS CONNECTED. THE EXTRACORPOREAL BLOOD WAS NOT RETURNED TO THE PATIENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8975450 ↗
• MalfunctionAug 22, 2019Fluid/Blood Leak; Loose or Intermittent Connection; Fluid/Blood Leak; Loose or Intermittent Connection

  IT WAS REPORTED DURING TREATMENT WITH A REVACLEAR 400 DIALYZER, AN EXTERNAL BLOOD LEAK WAS OBSERVED ¿THROUGH THE UPPER ORIFICE OF DIALYZER WHERE THE LUER LOCK CONNECTION IS MADE TO THE ARTERIAL LINE¿. IT WAS REPORTED ¿THE CONNECTION LOOSENS¿ OVER THE COURSE OF THE THERAPY, WHICH LEAD TO A BLOOD LOSS (VOLUME NOT REPORTED). THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8921215 ↗
• MalfunctionAug 14, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED DURING TREATMENT WITH TEN UNITS OF REVACLEAR 400 DIALYZERS, EXTERNAL BLOOD LEAKS WERE OBSERVED FROM THE CONNECTION BETWEEN ¿THE UPPER ORIFICE OF THE DIALYSER WHERE THE LUER LOCK CONNECTION IS MADE TO THE ARTERIAL LINE OF THE HEMODIALYSIS SYSTEM¿. THE EVENTS OCCURRED IN PATIENTS WHO WERE PERFORMING HEMODIALYSIS WITHOUT HEPARIN ¿FROM THE THIRD HOUR OF THERAPY¿. THE VOLUME OF EXTERNAL BLOOD LOSS WAS NOT REPORTED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8892903 ↗
• MalfunctionAug 13, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THREE UNITS OF REVACLEAR PRESENTED A LEAK THROUGH THE UPPER ORIFICE OF THE DIALYSER WHERE THE LUER LOCK CONNECTS TO THE ARTERIAL LINE OF THE HEMODIALYSIS SYSTEM. THE EVENT WAS REPORTED TO HAVE OCCURRED DURING THE THIRD HOUR OF THERAPY, ON AN UNSPECIFIED NUMBER OF PATIENTS WHO WERE PERFORMING HEMODIALYSIS WITHOUT HEPARIN. THERE WAS PATIENT INVOLVEMENT, BUT NO ADVERSE EVENT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8889001 ↗
• MalfunctionApr 17, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED DURING TREATMENT WITH A REVACLEAR 400 DIALYZER, AN EXTERNAL DIALYSATE LEAK WAS OBSERVED ¿JUST BELOW¿ THE TOP COVER OF THE DIALYZER. THE EVENT OCCURRED IN THE FIRST HOUR OF TREATMENT. TREATMENT WAS CONTINUED WITH A NEW SET. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8525601 ↗
• MalfunctionApr 12, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED DURING TREATMENT WITH A REVACLEAR 400 DIALYZER AN EXTERNAL DIALYSATE LEAK WAS OBSERVED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8509239 ↗
• MalfunctionMar 25, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT SOLUTION LEAKED FROM THE BODY OF A REVACLEAR 400 DIALYZER. THIS OCCURRED DURING THE FIRST HOUR OF HEMODIALYSIS TREATMENT. THE DIALYZER WAS REPLACED AND THE PATIENT CONTINUED THERAPY WITH NO FURTHER ISSUES REPORTED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8448293 ↗
• InjuryMar 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO MINUTES AFTER STARTING TREATMENT USING AN AK 96 DIALYSIS MACHINE WITH A REVACLEAR 400 DIALYZER, THE PATIENT EXPERIENCED "MUCH ITCHINESS", BLOOD PRESSURE ¿WENT VERY LOW¿ AND ¿DIFFICULTY BREATHING FOR A SECOND¿. IT WAS ALSO REPORTED THE PATIENT HAD NO BREATHING PROBLEMS. NO NUMERICAL VALUES OR PRETREATMENT BLOOD PRESSURES WERE REPORTED. THE PATIENT WAS DISCONNECTED FROM THE DIALYSIS CIRCUIT AND IT WAS REPORTED ¿ALL THE SYMPTOMS SUBSIDED¿. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Dyspnea; Low Blood Pressure/ Hypotension

  MAUDE report 8420892 ↗
• InjuryMar 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 18 PATIENTS USING A REVACLEAR 400 EXPERIENCED CHILLS, HEADACHE, MALAISE AND NAUSEA DURING THERAPY. THE PATIENTS WERE TREATED WITH 100MG OF HYDROCORTISONE INTRAVENOUSLY, 75MG OF DICLOFENAC, 3LT X1MTS OF OXYGEN AND 1G OF VANCOMYCIN WAS ADMINISTERED INTRAVENOUSLY. IT WAS REPORTED THAT THE PATIENTS IMPROVED AFTER TREATMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Chills; Headache; Malaise; Nausea

  MAUDE report 8386195 ↗
• MalfunctionDec 18, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING SET-UP WITH A REVACLEAR 400 SET, ¿SOME STAINS¿ WERE OBSERVED INSIDE THE FIBERS OF THE DIALYZER. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 8176134 ↗
• MalfunctionAug 29, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT TWO (2) UNITS OF THERANOVA 400 HAD AN EXTERNAL BLOOD LEAKAGE FROM THE HEADER OF THE DIALYZER DURING PATIENT THERAPY. 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 7827863 ↗
• MalfunctionAug 29, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A REVACLEAR 400 HAD A DIALYSATE FLUID LEAKING FROM THE ENDCAP JOINT AREA APPROXIMATELY 1.5 HOURS INTO PATIENT TREATMENT. ONCE THE LEAK WAS OBSERVED, THE ENTIRE BLOOD CIRCUIT AND THE DIALYZER WERE CHANGED. 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 7827581 ↗
• MalfunctionApr 20, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT ONE HOUR BEFORE THE END OF THERAPY, AN EXTERNAL SOLUTION LEAKAGE WAS NOTED FROM THE BOTTOM OF A REVACLEAR 400 DIALYZER. NO ALARMS WERE DISPLAYED. THE BLOOD IN THE CIRCUIT WAS RETURNED TO THE PATIENT AND THE FILTER WAS CHANGED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7448635 ↗
• MalfunctionApr 3, 2018Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  REPORTEDLY, A BLOOD LEAK WAS DETECTED 3 HOURS AFTER THE TREATMENT BEGAN, AT THE CONNECTION OF THE REVACLEAR 400 DIALYZER TO THE ARTERIAL DIALYZER LINE. THE PRESENCE OF COAGULATED BLOOD WAS NOTED AT THE LEVEL OF THE INLET AND OUTLET CONNECTORS OF THE DIALYZER. ACCORDING TO THE REPORTER, THE ARTERIAL EXPANSION CHAMBER WAS UNDER HIGH PRESSURE, A CLOT IN THE LINE WAS NOTICED, WHICH IN TURN LED TO AN OVERPRESSURE ON THE VENOUS LINE. THE SESSION WAS DISCONTINUED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7393468 ↗
• MalfunctionMar 26, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A BLOOD LEAK FROM A REVACLEAR 400 DIALYZER. THE BLOOD WAS NOT RETURNED TO THE PATIENT, LEADING TO A BLOOD LOSS OF APPROXIMATELY 300ML. THE REPORTER CHECKED THE CONNECTIONS AND THE LINES WERE CONNECTED PROPERLY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7372429 ↗