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REXEED 21SRecalls & reported problems

Asahikasei Medical Mt K.K. · Intended for use in hemodialysis for the treatment of patients suffering from acute or chronic 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 04537693003910), received between Oct 6, 2020 and Oct 6, 2020 — classified as 1 malfunction.

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

  • Fluid/Blood Leak1

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.

  • MalfunctionOct 6, 2020Fluid/Blood Leak; Fluid/Blood Leak

    DIALYZER CRACKED 30 MINUTES AFTER STARTING THE TREATMENT WITH BLOOD FLOW RATE AT 450 ML/MIN, AND DIALYSATE FLOW RATE AT 800 ML/MIN. EXTERNAL BLOOD LEAKAGE WAS FOUND FROM THE ARTERIAL, AND VENOUS HEADERS BY VISUAL OBSERVATION. APPROXIMATE BLOOD VOLUME LOSS WAS 50 ML. THE PATIENT WAS STABLE AND DID NOT NEED ANY MEDICAL INTERVENTION. DIALYZERS WITH SAME LOT NUMBER WERE USED WITH NO PROBLEM.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10633148 ↗

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