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BiCart 1250Recalls & reported problems

Vantive Health GmbH · Sodium Bicarbonate for Hemodialysis · 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 07332414110574), received between Mar 29, 2023 and Mar 29, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Contamination” (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

  • Contamination1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionMar 29, 2023Contamination

    BLACK FLECKS FLOATING IN BICART AFTER A HEMODIALYSIS TREATMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16635058 ↗

Other DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) devices

All DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) devices →

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