Skip to content

Perfusion Pack (UDI 00803622133374)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 00803622133374), received between Jul 8, 2022 and Jul 8, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Misassembled During Manufacturing /Shipping” (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

  • Device Misassembled During Manufacturing /Shipping1

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.

  • MalfunctionJul 8, 2022Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

    LIVANOVA USA RECEIVED A REPORT THAT DURING INSTALLATION OF THE CIRCUIT, THE TUBING DISCONNECTED FROM THE CONNECTOR EVEN WHEN ITS TIE BANDED. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14955288 ↗

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