REVACLEARRecalls & reported problems across all models

We found 2 models of REVACLEAR by Gambro Renal Products, Inc. in the FDA's device registry (GUDID). Together they are named in 169 adverse event reports in the FDA's MAUDE database, received between Jan 19, 2018 and Apr 4, 2025 — classified as 1 death, 16 injuries, 152 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (98 reports).

6 FDA recall records name at least one of these models by its device identifier, 3 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, 2022Class IIOpen, 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 ↗

2. Nov 23, 2022Class IIOpen, Classified

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

   Z-0762-2023 · Root cause: Process control · Recall details · FDA record ↗

3. Nov 23, 2022Class IIOpen, Classified

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

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

4. Nov 15, 2019Class IITerminated

   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 · Recall details · FDA record ↗

5. May 31, 2019Class IITerminated

   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 · Recall details · FDA record ↗

6. May 31, 2019Class IITerminated

   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 · Recall details · FDA record ↗

Most reported REVACLEAR problems

REVACLEAR models

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

• REVACLEAR 300

  Dialyzer, high permeability with or without sealed dialysate system
  3 recalls125 reports
• REVACLEAR 400

  Dialyzer, high permeability with or without sealed dialysate system
  3 recalls1 death44 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.

• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗