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Perfusion Pack (UDI 00803622113338)Recalls & reported problems

Livanova USA, Inc.

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00803622113338), received between Feb 1, 2019 and Feb 21, 2020 — classified as 2 malfunctions.

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

  • Disconnection1
  • Misassembled1

Patient problems

  • Death1
  • No Patient Involvement1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 21, 2020Misassembled; Misassembled

    LIVANOVA USA INC HAS RECEIVED A REPORT THAT, DURING PRIMING, THE MEDICAL TEAM IDENTIFIED THAT THE YELLOW AND WHITE CLAMPS WERE ON REVERSED LINES IN CARDIOPLEGIA SET UP. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Patient Involvement

    MAUDE report 9738125 ↗
  • MalfunctionFeb 1, 2019Disconnection; Disconnection

    LIVANOVA USA HAS BEEN INFORMED THAT, DURING A BYPASS, THE TUBING CONNECTION ON THE OXYGENATOR INLET COMPLETELY DISCONNECTED. DURING FOLLOW UP INFORMATION, LIVANOVA USA HAS BEEN INFORMED THE PATIENT HAS DIED 2 DAYS AFTER THE EVENT.

    Patient problems: Death

    MAUDE report 8298028 ↗

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