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Perfusion Pack (UDI 00803622126017)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 00803622126017), received between Oct 27, 2016 and Oct 27, 2016 — 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 Patient Involvement1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 27, 2016Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

    SORIN GROUP RECEIVED A REPORT THAT THE ARTERIAL FILTER WAS FOUND TO HAVE BEEN PLACED BACKWARDS INTO THE LINE OF THE CUSTOM PERFUSION TUBING SET DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Patient Involvement

    MAUDE report 6059784 ↗

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