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Cardioplegia Pack (UDI 00803622133671)Recalls & reported problems

Livanova USA, Inc.

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 00803622133671), received between Apr 21, 2022 and Apr 21, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Component Misassembled” (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

  • Component Misassembled1

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.

  • MalfunctionApr 21, 2022Component Misassembled; Component Misassembled

    LIVANOVA USA INC HAS RECEIVED A REPORT THAT, AFTER A FEW TIMES OF TRYING TO GIVE CARDIOPLEGIA AND NOT BEING SUCCESSFUL AND THE SURGEON NOTICED THAT THE RED AND BLUE TAPES WERE NOT THE SAME ON OPPOSITE ENDS OF THE TUBING. ONCE DISCOVERED THEY WERE ABLE TO WORK THINGS OUT AND COMPLETE THE PROCEDURE. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14166757 ↗

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