REVACLEAR 300 (REF 114745L)Recalls & reported problems

Summary

The FDA's MAUDE database contains 125 adverse event reports that list this exact device (DI 07332414123055), received between Jan 19, 2018 and Jan 6, 2025 — classified as 13 injuries, 112 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (71 reports).

3 FDA recall records name this device's 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, 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-0762-2023 · Root cause: Process control · FDA record ↗

2. Nov 15, 2019Terminated

   There is the potential presence of particular matter in the header caps of ten lots the Revaclear 300 Dialyzer.

   Z-1409-2020 · Root cause: Process 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-1908-2019 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 125 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM AN UNSPECIFIED LOCATION 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 21084613 ↗
• MalfunctionJun 24, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM THE END CAP OF A REVALCEAR 300 DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19601527 ↗
• InjuryJun 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THREE MINUTES AFTER STARTING TREATMENT WITH A REVACLEAR 300 DIALYZER, THE PATIENT EXPERIENCED BACK PAIN, ITCHING, NAUSEA AND VOMITING, COLD/CLAMMY SKIN AND PALLOR, LIGHTHEADED, SHORTNESS OF BREATH AND DECREASED SYSTOLIC BLOOD PRESSURE TO "90S" . THE TREATMENT WAS DISCONTINUED,AND THE DIALYZER WAS REPLACED WITH A NON-BAXTER DIALYZER. THE PATIENT WAS GIVEN BENADRYL AND NORMAL SALINE AS TREATMENT. THE PATIENT¿S SYMPTOMS HAD "MARGINAL IMPROVEMENT". DIALYSIS TREATMENT WAS TERMINATED 2 HOURS AND 45 MINUTES EARLY AND THE PATIENT WAS SENT TO THE EMERGENCY ROOM VIA AMBULANCE. THE PATIENT WAS NOT ADMITTED TO THE HOSPITAL. THE PATIENT RETURNED TO THE DIALYSIS CLINIC THE FOLLOWING DAY TO "MAKE UP THE TREATMENT". NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Dizziness; Dyspnea; Hypersensitivity/Allergic reaction; Itching Sensation; Low Blood Pressure/ Hypotension; Nausea; Pain; Pallor; Vomiting

  MAUDE report 19538843 ↗
• MalfunctionSep 19, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED UNSPECIFIED PARTICULATE WAS OBSERVED IN SIXTEEN (16) STERILIZED REVACLEAR 300 SETS. THE PARTICULATE WAS NOTED DURING AN UNKNOWN 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 17773219 ↗
• MalfunctionSep 19, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED UNSPECIFIED PARTICULATE WAS OBSERVED IN SIXTEEN (16) STERILIZED REVACLEAR 300 SETS. THE PARTICULATE WAS NOTED DURING AN UNKNOWN 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 17773180 ↗
• InjurySep 7, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT APPROXIMATELY THREE MINUTES AFTER STARTING TREATMENT WITH REVACLEAR 300, A BLOOD LEAK ALARM WAS GENERATED. BLOOD WAS OBSERVED IN THE DIALYSATE PATH. TREATMENT WAS STOPPED. IT WAS FURTHER REPORTED THE BLOOD WAS NOT RETURNED TO THE PATIENT AND A BLOOD TRANSFUSION WAS ADMINISTERED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 17697758 ↗
• MalfunctionJun 26, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED AN EXTERNAL BLOOD LEAK WAS OBSERVED ORIGINATING FROM THE ¿TOP OF THE DIALYZER ON THE OUTSIDE¿ OF AN UNSPECIFIED QUANTITY OF REVACLEAR 300 SETS DURING HEMODIALYSIS THERAPY. THE VOLUME OF BLOOD LOST WAS NOT REPORTED FOR ANY OF THE EVENTS. 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 17199404 ↗
• MalfunctionJun 26, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED AN EXTERNAL BLOOD LEAK WAS OBSERVED ORIGINATING FROM THE ¿TOP OF THE DIALYZER ON THE OUTSIDE¿ OF A REVACLEAR 300 SET DURING HEMODIALYSIS THERAPY. THE VOLUME OF BLOOD LOST 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 17199402 ↗
• MalfunctionJun 26, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED AN EXTERNAL BLOOD LEAK WAS OBSERVED ORIGINATING FROM THE ¿TOP OF THE DIALYZER ON THE OUTSIDE¿ OF A REVACLEAR 300 SET DURING HEMODIALYSIS THERAPY. THE VOLUME OF BLOOD LOST 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 17199401 ↗
• MalfunctionMay 24, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED AN EXTERNAL BLOOD LEAK WAS OBSERVED ORIGINATING FROM AT THE FILTER'S VENOUS CONNECTOR OF A REVACLEAR 300 APPROXIMATELY ¿FIVE MINUTES¿ INTO HEMODIALYSIS THERAPY. THE BLOOD LEAK ALARM WAS TRIGGERED. 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 16994937 ↗
• MalfunctionMay 24, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED AN EXTERNAL BLOOD LEAK WAS OBSERVED ORIGINATING FROM AN UNSPECIFIED LOCATION OF A REVACLEAR 300 DURING 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 16993780 ↗
• MalfunctionMay 24, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED TWO (2) EXTERNAL BLOOD LEAKS WERE OBSERVED ORIGINATING FROM AN UNSPECIFIED LOCATION OF A REVACLEAR 300 DURING 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 16993441 ↗
• InjuryMay 22, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING TREATMENT WITH A REVACLEAR 300, THE MACHINE TRIGGERED AN INTERNAL BLOOD LEAK ALARM, TREATMENT WAS DISCONTINUED AND THE EXTRACORPOREAL CIRCUIT WAS NOT RETURNED TO THE PATIENT. THE PATIENT PRESENTED TO THE HOSPITAL DUE TO AN ESTIMATED BLOOD LOSS OF 900ML. THE PATIENT EXPERIENCED SHORTNESS OF BREATH AND AN OVERALL FEELING OF MALAISE. OXYGEN WAS ADMINISTERED TO THE PATIENT. THE PATIENT RECEIVED DIALYSIS AT THE HOSPITAL IN AN ACUTE SETTING WITH NO ISSUES. THE PATIENT WAS DISCHARGED THE SAME DAY. THE PATIENT OUTCOME WAS REPORTED AS "GOOD". THE PATIENT HAS SINCE DIALYZED PER THEIR NORMAL SCHEDULE IN THE CLINIC WITH NO ISSUES NOTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 16981263 ↗
• InjuryMay 22, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER STARTING TREATMENT WITH A REVACLEAR 300, THE DIALYZER TURNED VERY DARK, "ALMOST BLACK" AFTER THE BLOOD HIT THE DIALYZER. THE BLOOD RETURN WAS STARTED; HOWEVER ; THEN STOPPED DUE TO THE PATIENT COMPLAINING OF SHORTNESS OF BREATH AND RESTLESSNESS. THE EXTRACORPOREAL CIRCUIT WAS NOT RETURNED TO THE PATIENT. OXYGEN WAS ADMINISTERED TO THE PATIENT, AND THE PATIENT REPORTED THEY FELT "MUCH BETTER". TREATMENT WAS THEN RESTARTED WITH A DIFFERENT REVACLEAR 300 DIALYZER FROM SAME LOT, HOWEVER, THE MACHINE TRIGGERED AN INTERNAL BLOOD LEAK ALARM, AND THE EXTRACORPOREAL CIRCUIT WAS NOT RETURNED TO THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 16975610 ↗
• InjuryApr 17, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED TWO (2) INTERNAL BLOOD LEAKS WERE OBSERVED IN A REVACLEAR 300. FORTY MINUTES INTO HEMODIALYSIS THERAPY, THE UNSPECIFIED HEMODIALYSIS MACHINE ALARMED INTERNAL BLOOD LEAK. THE PATIENT LOST 250ML OF BLOOD. THE PATIENT WAS RESTARTED ON A NEW MACHINE AND NEW REVACLEAR (FROM THE SAME LOT). AGAIN 40 MINUTES INTO THERAPY, THE MACHINE ALARMED INTERNAL BLOOD LEAK. THE PATIENT LOST ANOTHER 250ML OF BLOOD. THE PATIENT WAS SET UP WITH A NEW MACHINE AND A REVACLEAR FROM A DIFFERENT LOT NUMBER. THERAPY WAS COMPLETED WITH NO ISSUES. THE FOLLOWING DAY, THE PATIENT UNDERWENT A BLOOD TRANSFUSION. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 16755799 ↗
• MalfunctionMar 28, 2023Material Twisted/Bent

  NEW DIALYZER OPENED TO PLACE ON THE MACHINE. UPON INSPECTION, THE FIBERS WERE BENT AND LOOK AS IF THEY ARE NOT CONNECTED AS THEY SHOULD BE. DIALYZER PULLED FROM USE.

  Patient problems: Insufficient Information

  MAUDE report 16627223 ↗
• MalfunctionJan 6, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING USE WITH A REVACLEAR, AN EXTERNAL BLOOD LEAK WAS OBSERVED. THE 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 16111800 ↗
• MalfunctionJan 5, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING THE PRIMING OF A REVACLEAR 300, A SALINE SOLUTION LEAKAGE THROUGH THE FIBERS WAS OBSERVED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16102944 ↗
• MalfunctionDec 28, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING THE PRIMING OF A REVACLEAR 300 , A SALINE SOLUTION LEAKAGE WAS OBSERVED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16059598 ↗
• MalfunctionDec 20, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING PRIMING WITH A REVACLEAR 300, A SALINE SOLUTION LEAK WAS OBSERVED THROUGH ONE OF THE ENDS OF THE FILTER. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16014971 ↗
• MalfunctionNov 22, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING TREATMENT WITH ONE UNIT OF REVACLEAR 300 , AN EXTERNAL BLOOD LEAK 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 15841335 ↗
• MalfunctionSep 28, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER FIVE MINUTES OF TREATMENT WITH ONE UNIT OF REVACLEAR 300, AN EXTERNAL FLUID LEAKAGE WAS NOTED FROM THE TOP OF THE DIALYZER PORT. 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 15496615 ↗
• MalfunctionAug 2, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING PRIMING WITH A REVACLEAR 300, AN EXTERNAL FLUID LEAK "FROM ONE OF THE ENDS" WAS OBSERVED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15147720 ↗
• MalfunctionApr 11, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT HAIR WAS OBSERVED UPON OPENING ONE UNIT OF REVACLEAR 300. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14075124 ↗
• MalfunctionFeb 11, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING PRIMING WITH A REVACLEAR 300, AN EXTERNAL DIALYSATE LEAKAGE AT THE LEVEL OF THE VENOUS POLE WAS OBSERVED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13518077 ↗