Skip to content

Perfusion Pack (UDI 00803622141089)Recalls & reported problems

Livanova USA, Inc.

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00803622141089), received between Oct 18, 2022 and Nov 11, 2022 — classified as 1 injury, 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

  • Hypovolemia1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionNov 11, 2022Disconnection; Disconnection

    SEE INTIAL REPORT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15778540 ↗
  • InjuryOct 18, 2022Fluid/Blood Leak; Fluid/Blood Leak

    ON (B)(6) 2022, SORIN GROUP ITALIA RECEIVED A USER MEDWATCH REPORT (MW5111793) STATING THAT PATIENT WAS BEING SUPPORTED ON VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) AND THE ECMO CIRCUIT, WHICH CARRIES THE BLOOD FROM PATIENT TO OXYGENATOR AND BACK TO THE PATIENT, DEVELOPED A SIGNIFICANT LEAK. LEAK IDENTIFIED AT BONDED LOCATIONS IN THE CIRCUIT. SIGNIFICANT BLOOD LOSS WHICH REQUIRED CHANGE OUT OF THE CIRCUIT.

    Patient problems: Hypovolemia

    MAUDE report 15623916 ↗

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