Skip to content

Exeltra Dialyzer 170Recalls & reported problems

Baxter International Inc. · Hemodialysis with EXELTRA and EXELTRA Plus dialyzers is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs. · Class 2

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00085412071213), received between May 29, 2018 and May 29, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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

Device problems

  • Fluid/Blood Leak3
  • Loose or Intermittent Connection2

Patient problems

  • No Consequences Or Impact To Patient3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 29, 2018Fluid/Blood Leak; Loose or Intermittent Connection; Fluid/Blood Leak; Loose or Intermittent Connection

    IT WAS REPORTED THAT THERE WAS A POOR CONNECTION BETWEEN THE DIALYZER AND THE BLOODLINES. THE CONNECTIONS DID NOT FEEL SECURE TO THE CUSTOMER AND THERE WAS SOME BLOOD LEAKING AROUND THE CONNECTIONS. THE REPORTER STATED THAT IT TOOK EFFORT TO ENSURE THAT THE LINES WERE SEATED JUST RIGHT. THIS ISSUE WAS NOTED ABOUT ONE HOUR INTO THE THERAPY. THE THERAPY WAS DISCONTINUED AND A NEW SET WAS USED. 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 7548929 ↗
  • MalfunctionMay 29, 2018Fluid/Blood Leak; Loose or Intermittent Connection; Fluid/Blood Leak; Loose or Intermittent Connection

    IT WAS REPORTED THAT THERE WAS A POOR CONNECTION BETWEEN THE DIALYZER AND THE BLOODLINES. THE CONNECTION FELT LOOSE AND DID NOT SEAT PROPERLY, BUT NO DAMAGE WAS NOTICED TO THE COMPONENTS. THERE WAS SOME BLOOD OOZING AROUND THE CONNECTION. THE REPORTER STATED THE LINE HAD TO BE TIGHTENED DURING THERAPY. 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 7548827 ↗
  • MalfunctionMay 29, 2018Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED THAT THERE WERE FOUR (4) INSTANCES WHERE SOME BLOOD WAS OOZING AROUND THE CONNECTION OF THE DIALYZER TO THE BLOOD LINES. THIS OCCURRED WITH THE SAME PATIENT. 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 7548807 ↗

Other Dialyzer, high permeability with or without sealed dialysate system devices

All Dialyzer, high permeability with or without sealed dialysate system devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.