POLYFLUX REVACLEAR MAX 110634Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07332414101701), received between Mar 20, 2018 and Sep 25, 2018 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERGOING TREATMENT WITH A REVACLEAR MAX DIALYZER EXPERIENCED HYPERSENSITIVITY REACTIONS. ON THE DATE OF ONSET OF REACTIONS, NO MEDICAL INTERVENTION WAS REPORTED FOR THIS OCCURRENCE. TWO DAYS LATER AND 15 MINUTES INTO TREATMENT WITH THE SAME DIALYZER, THE PATIENT EXPERIENCED A ¿FIRST ANAPHYLACTIC REACTION¿ AND WAS LATER HOSPITALIZED THAT SAME DAY. THE PATIENT WAS TREATED WITH AND AN EPI-PEN (EPINEPHRINE INJECTION). TWO DAYS LATER, THE PATIENT WHILE UNDERGOING TREATMENT WITH THE SAME DEVICE, EXPERIENCED A "SEVERE ANAPHYLACTIC REACTION". THE PATIENT'S SYMPTOMS AT TIME OF REACTION RANGED FROM ¿HIVES, CLOSING OF THROAT, DIFFICULT BREATHING, WEAVING¿. AN EPI-PEN WAS ADMINISTERED AND THE SYMPTOMS DECREASED. AT THE TIME OF THIS REPORT, THE PATIENT WAS STILL HOSPITALIZED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Anaphylactic Shock; Respiratory Distress

  MAUDE report 7907912 ↗
• MalfunctionMay 4, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A LEAK FROM A REVACLEAR MAX DIALYZER DURING USE. THERE WAS A DROP OF DIALYSATE THAT LEAKED FROM THE BOTTOM OF THE DIALYZER. THE DIALYZER WAS REPLACED WITH A NEW ONE TO RESOLVE THE ISSUE. 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 7487556 ↗
• MalfunctionMar 20, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A NURSE REPORTED AN UNKNOWN BLACK DOT ON THE TIP OF THE REVACLEAR DIALYZER STRANDS. THE CUSTOMER STATED THAT THE PARTICLE WAS FOUND ON THE INSIDE OF THE TOP END OF THE DIALYZER. THIS WAS NOTED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 7355498 ↗
• MalfunctionMar 20, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A NURSE REPORTED PARTICULATE MATTER INSIDE A REVACLEAR MAX DIALYZER. THE CUSTOMER REPORTED THAT THE PARTICLE WAS FOUND ON THE INSIDE OF THE TOP END OF THE DIALYZER. THIS WAS NOTICED BEFORE USE ON PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 7355457 ↗