REVACLEAR 400 (REF 114746L)Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 07332414124076), received between Oct 17, 2018 and Apr 4, 2025 — classified as 1 death, 3 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (27 reports).

3 FDA recall records name this device's identifier, 2 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

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 · FDA record ↗

2. Nov 23, 2022Open, Classified

   Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer

   Z-0760-2023 · Root cause: Process change control · FDA record ↗

3. May 31, 2019Terminated

   There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.

   Z-1909-2019 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING USE WITH REVCLEAR 400 DIALYZER ¿MULTIPLE BAGS WERE NOT SEALED AND WOULD LEAK WHILE IN USE¿. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. THERE WAS NO CONTACT INFORMATION PROVIDED TO FOLLOW UP WITH THE REPORTER TO CLARIFY WHAT WAS MEANT BY THE BAG, IN ADDITION, THE REPORTER INDICATED THEY DID NOT WANT TO BE CONTACTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21775122 ↗
• MalfunctionAug 21, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A LEAK WAS OBSERVED FROM A REVACLEAR 400 DURING AN UNSPECIFIED PROCESS STEP. 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 20022052 ↗
• MalfunctionMar 26, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED ONE UNIT OF REVACLEAR 400 LEAKED FROM THE UPPER PART OF THE FILTER BODY. A CRACK WAS OBSERVED WHERE THE LEAK OCCURRED. THE ISSUE OCCURRED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18983394 ↗
• MalfunctionFeb 16, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL BLOOD LEAK WAS OBSERVED FROM A REVACLEAR 400 DURING HEMODIALYSIS THERAPY. THE VOLUME OF BLOOD LOSS WAS NOT KNOWN. THERE WAS NO REPORT OF MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18722172 ↗
• MalfunctionSep 8, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED AN EXTERNAL FLUID LEAK WAS OBSERVED ORIGINATING FROM THE TOP OF A REVACLEAR 400 DIALYZER FORTY MINUTES INTO HEMODIALYSIS THERAPY. 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 17715777 ↗
• MalfunctionAug 10, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED AN EXTERNAL FLUID LEAK WAS OBSERVED ORIGINATING FROM A CRACK IN THE HARD PLASTIC CONTAINING THE FILTER OF A REVACLEAR 400 DURING PRIME. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17502572 ↗
• MalfunctionMay 30, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING TREATMENT WITH DIALYSIS USING A REVACLEAR 400, AN EXTERNAL BLOOD LEAK WAS OBSERVED FROM THE TOP OF THE DIALYZER. 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 17019668 ↗
• MalfunctionApr 10, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED TWO (2) REVACLEAR 400 EXPERIENCED AN INTERNAL BLOOD LEAK. DURING HEMODIALYSIS THERAPY THE EXTRACORPOREAL SYSTEM WAS OBSERVED FULL, AND THE CAPILLARY MEMBRANE RUPTURED. THERAPY WAS SUSPENDED AND THE COMPLETE SYSTEM WAS CHANGED. THERAPY WAS RESTARTED AND THE EVENT REOCCURRED. THERAPY WAS DISCONTINUED AND THE SET WAS DISCARDED. THE PATIENT LOST A TOTAL OF 400ML OF BLOOD. 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 16708959 ↗
• MalfunctionMar 20, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED BLACK PARTICULATE WAS OBSERVED IN THE HEADER OF A REVACLEAR 400. THE EVENT OCCURRED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16577081 ↗
• MalfunctionNov 30, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WHICH WAS OBSERVED FROM THE BASE OF THE FILTER (ARTERIAL PART) OF A REVACLEAR 400. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15891434 ↗
• MalfunctionNov 16, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING TREATMENT WITH A REVACLEAR 400, DRIED BLOOD WAS OBSERVED AT THE CONNECTION FROM THE BLOOD LINE TO THE ARTERIAL PORT OF THE DIALYZER AND THERE WAS EVIDENCE OF DRIED BLOOD APPROXIMATELY 10CM DISTAL TO THE PORT. APPROXIMATELY 30 ML OF DRIED AND FRESH BLOOD WAS ALSO OBSERVED IN THE GARBAGE CAN UNDER THE LINES. 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 15804814 ↗
• MalfunctionNov 16, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL BLOOD LEAK WAS OBSERVED ON A REVACLEAR 400 DUE TO A BROKEN UNION OF ONE OF THE FILTER HEADS. THE EVENT OCCURRED DURING PATIENT USE. 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 15804506 ↗
• MalfunctionNov 15, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING USE, TWO (2) UNITS OF REVACLEAR 400 HAD AN EXTERNAL BLOOD LEAK. BLOOD WAS NOT RETURNED TO THE PATIENT BOTH TIMES. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15798702 ↗
• MalfunctionNov 9, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING TREATMENT WITH A REVACLEAR 400, AN EXTERNAL BLOOD LEAK OF APPROXIMATELY 400 ML WAS OBSERVED AT THE TOP OF THE DIALYZER WHERE ARTERIAL LINE CONNECTS TO THE DIALYZER. BLOOD WAS NOT 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 15759846 ↗
• MalfunctionNov 3, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER THE FIRST FIVE (5) MINUTES OF TREATMENT, AN EXTERNAL BLOOD LEAK WAS OBSERVED ON A REVACLEAR 400. FURTHER DESCRIBED AS BLOOD WAS "POOLING/LEAKING" AT THE TOP AND BOTTOM OF THE DIALYZER. 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 15721983 ↗
• MalfunctionNov 2, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING USE, ONE UNIT OF REVACLEAR 400 BLOOD LEAK WAS OBSERVED IN END OF THE DIALYZER. THE MACHINE DID NOT ALARM. 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 15716146 ↗
• MalfunctionNov 2, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT 45 MINUTES INTO TREATMENT WITH A REVACLEAR 400, AN EXTERNAL BLOOD LEAK WAS OBSERVED IN THE TOP SECTION OF THE DIALYZER WHERE THE CAP IS SCREWED ONTO THE BODY OF THE DIALYZER ITSELF. NO DRIPPING OCCURRED OUTSIDE OF THE THREADS OR ALARMS ON THE MACHINE.THE BLOOD WAS PRESENT IN THE THREADS THAT CONNECT THE TOP OF THE DIALYZER TO THE CYLINDRICAL BODY OF THE DIALYZER. 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 15715993 ↗
• MalfunctionNov 2, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING TREATMENT WITH A REVACLEAR 400, AN EXTERNAL BLOOD LEAK WAS OBSERVED DUE TO THE ¿BLOODLINE WAS NOT PROPERLY CONNECTED (LOOSELY CONNECTED) TO DIALYZER¿. THE TREATMENT WAS ENDED WITHOUT BLOOD RESTITUTION. THE PATIENT WAS ADMINISTERED VANCOMYCIN AND GENTAMICIN (2 DOSES INTRAVENOUSLY) AS A PRECAUTIONARY MEASURE.THERE WAS NO REPORT OF PATIENT INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE. .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15715911 ↗
• MalfunctionOct 27, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING TREATMENT WITH A REVACLEAR 400, AN EXTERNAL BLOOD LEAK AT THE ARTERIAL SEGMENT WAS OBSERVED. 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 15681786 ↗
• MalfunctionOct 27, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING USE WITH A REVACLEAR 400, AN EXTERNAL BLOOD LEAK AT THE TOP AND BOTTOM OF DIALYZER WAS OBSERVED. THE TREATMENT WAS ENDED WITH PARTIAL BLOOD RESTITUTION. 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 15680323 ↗
• MalfunctionOct 26, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING USE WITH A REVACLEAR 400 , AN EXTERNAL BLOOD LEAK AT THE TOP AND BOTTOM OF THE O-RING WAS OBSERVED. 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 15677849 ↗
• MalfunctionOct 26, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 10 MINUTES INTO HEMODIALYSIS TREATMENT USING A REVACLEAR 400, AN "EXTERNAL LEAKAGE" AS WELL AS "SEVERE BLOOD LEAK ALARM" ALARM WERE GENERATED. APPROXIMATELY 1/2 ML OF BLOOD WAS OBSERVED LEAKING OUT OF THE TOP OF THE DIALYZER. TREATMENT WAS IMMEDIATELY STOPPED AND BLOOD WAS NOT RETURNED TO THE PATIENT. THE PATIENT WAS DISCONNECTED FROM THE LINES AND THE MACHINE. ANCEF (2G) WAS GIVEN TO THE PATIENT POST DIALYSIS PER DOCTOR ORDERS.THERE WAS PATIENT INVOLVEMENT HOWEVER, NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15677814 ↗
• InjuryOct 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AT THE END OF A HOME TREATMENT WITH A REVACLEAR 400, THE PATIENT EXPERIENCED HIVES AND A STIFF TONGUE. THE PATIENT WAS HOSPITALIZED AND TREATED WITH BENEDRYL. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 15621562 ↗
• MalfunctionOct 13, 2022Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT NEAR THE END OF DIALYSIS TREATMENT WITH A REVACLEAR 400, A FLUID LEAK WAS OBSERVED AND THE DIALYZER WAS FOUND TO BE BROKEN. 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 15594222 ↗
• MalfunctionOct 6, 2022Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT WHILE PRIMING A REVACLEAR 400, THE CONNECTOR WAS OBSERVED TO BE BROKEN RESULTING IN AN EXTERNAL SALINE SOLUTION LEAK. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15549835 ↗