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Perfusion Pack (UDI 00803622112324)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 00803622112324), received between Apr 15, 2021 and Apr 15, 2021 — 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

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 15, 2021Disconnection; Disconnection

    LIVANOVA USA INC. HAS RECEIVED A REPORT THAT, DURING THE PROCEDURE THE INLET OF THE OXYGENATOR TUBING DISCONNECTED FROM THE CARDIOPULMONARY MACHINE. THE SYSTEM IS ALL PRECONNECTED EXCEPT THIS PRESSURE TUBING THAT DISLODGED DURING THE PROCEDURE. PATIENT OUTCOME WAS NOT PROVIDED. A 3500A REPORT (REF (B)(4)) WAS RECEIVED AT LIVANOVA ON 16 MAR 2021.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11671616 ↗

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