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Perfusion Pack (UDI 00803622138331)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 00803622138331), received between Jul 7, 2021 and Jul 7, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Disconnection” (2 reports).

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

  • Disconnection2

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

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

  • MalfunctionJul 7, 2021Disconnection; Disconnection

    SEE INTIAL REPORT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12128538 ↗
  • MalfunctionJul 7, 2021Disconnection; Disconnection

    SEE INTIAL REPORT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12128532 ↗

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