POLYFLUX REVACLEAR 110633Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07332414101695), received between Apr 11, 2018 and Apr 17, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT WHITE CRYSTALIZED RESIDUES WERE FOUND INSIDE THE CAP OF A REVACLEAR DIALYZER, WHERE IT CONNECTS TO THE HANSEN CONNECTOR. THIS WAS NOTED WHEN THE CUSTOMER TOOK OUT THE DIALYZER OF THE PACKAGING AND WAS ABOUT TO SET UP ON THE MACHINE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 7438317 ↗
• MalfunctionApr 11, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THREE REVACLEAR DIALYZERS PRESENTED AN INTERNAL BLOOD LEAKAGE. THE REPORTER STATED THAT IMMEDIATELY AFTER STARTING THERAPY, THE NON-BAXTER MACHINE PRESENTED A ¿BLOOD LEAK DETECTED¿ ALARM. THE TREATMENT WAS STOPPED AND THE BLOOD IN THE CIRCUIT WAS NOT RETURNED TO THE PATIENT. A SECOND DIALYZER WAS THEN SET UP ON THE SAME MACHINE; AGAIN, THE MACHINE ALARMED. TREATMENT WAS STOPPED, AND THE BLOOD FROM THE SECOND DIALYZER WAS ALSO NOT RETURNED TO THE PATIENT. THE NURSE MOVED THE PATIENT TO A DIFFERENT NON-BAXTER DIALYSIS MACHINE. WITHIN MINUTES OF STARTING THE TREATMENT, THE MACHINE PRESENTED A ¿BLOOD LEAK DETECTED¿ ALARM. THE THIRD SETUP WAS TAKEN DOWN AND THE BLOOD WAS NOT RETURNED TO THE PATIENT. THE PATIENT WAS THEN SET UP A FOURTH TIME WITH A DIALYZER OF A DIFFERENT LOT NUMBER, AND WAS ABLE TO SUCCESSFULLY COMPLETE THERAPY. UPON FURTHER REVIEW BY THE CUSTOMER, THE THREE LEAKING DIALYZERS WERE FOUND TO HAVE COME FROM A DAMAGED BOX. 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 7423457 ↗