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Perfusion Pack (UDI 00803622123887)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 00803622123887), received between Jul 27, 2017 and Jul 27, 2017 — classified as 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

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionJul 27, 2017Disconnection; Disconnection

    SORIN GROUP RECEIVED A REPORT THAT THE ARTERIAL LINE TUBING OF THE CUSTOM PERFUSION TUBING SET DISCONNECTED DURING A PROCEDURE. THE DISCONNECTION OCCURRED JUST OUTSIDE OF THE PUMP RACEWAY ON THE POSITIVE PRESSURE SIDE. THE PERFUSIONIST RECONNECTED THE TUBING AND TIE-BANDED THE CONNECTION. THERE WAS NO REPORT OF PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6749136 ↗

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