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Polyflux 210HRecalls & reported problems

Gambro Dialysatoren GmbH · The Polyflux 210H is intended for use in hemodialysis, hemodiafiltration and hemofiltration for the treatment of chronic or acute renal failure · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07332414048198), received between Sep 20, 2018 and Sep 20, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (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

Device problems

  • Leak/Splash1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 20, 2018Leak/Splash; Leak/Splash

    IT WAS REPORTED THAT A POLYFLUX 210H HAD A BLOOD LEAK IN THE CONNECTION BETWEEN THE ARTERIAL LINE AND THE DIALYZER. THE EVENT OCCURRED DURING PATIENT TREATMENT. 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 7893970 ↗

Other DIALYZER, CAPILLARY, HOLLOW FIBER devices

All DIALYZER, CAPILLARY, HOLLOW FIBER devices →

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