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Perfusion Pack (UDI 00803622125980)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 00803622125980), received between Jan 28, 2019 and Jan 28, 2019 — classified as 1 malfunction.

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
  • 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.

  • MalfunctionJan 28, 2019Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

    LIVANOVA USA INC RECEIVED A REPORT THAT AFTER COMING OFF BYPASS AT THE END OF A CASE, DURING THE NIGHT, THE TUBING THAT HOOKS UP TO THE RESERVOIR SLIPPED OFF THE TERUMO RESERVOIR OUTLET AND SPILLED FLUID EVERYWHERE. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8281013 ↗

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