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Perfusion Pack (UDI 00803622131202)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 00803622131202), received between Oct 20, 2017 and Oct 20, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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

  • Fluid/Blood Leak1

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 20, 2017Fluid/Blood Leak; Fluid/Blood Leak

    SORIN GROUP (B)(6) RECEIVED A REPORT THAT PRIMING FLUID WAS OBSERVED LEAKING FROM THE BLOOD SIDE TO THE WATER SIDE OF THE INSPIRE 8F HOLLOW FIBER OXYGENATOR DURING PRIMING. THE CUSTOMER REPORTED THAT THE FLUID PASSED THROUGH WITH NO RESISTANCE. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Patient Involvement

    MAUDE report 6964226 ↗

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