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Perfusion Pack (UDI 00803622135187)Recalls & reported problems

Livanova USA, Inc.

Adverse event reports
4
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00803622135187), received between Jul 18, 2018 and Oct 19, 2018 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (4 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

  • Material Fragmentation4

Patient problems

  • No Consequences Or Impact To Patient2
  • No Patient Involvement2

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 19, 2018Material Fragmentation; Material Fragmentation

    LIVANOVA RECEIVED A REPORT THAT A METAL SHAVING WAS OBSERVED EXITING THE STAINLESS STEEL COOIING COIL OF THE CUSTOM PERFUSION TUBING SET DURING PRIMING AND RECIRCULATION. THE METAL SHAVING WAS CAUGHT IN THE REVERSE DRIP CHAMBER. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7985274 ↗
  • MalfunctionJul 31, 2018Material Fragmentation; Material Fragmentation

    LIVANOVA RECEIVED A REPORT THAT A METAL SHARD WAS OBSERVED COMING OUT OF THE METAL COIL OF THE CUSTOM PERFUSION TUBING SET DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Patient Involvement

    MAUDE report 7735142 ↗
  • MalfunctionJul 31, 2018Material Fragmentation; Material Fragmentation

    LIVANOVA RECEIVED A REPORT THAT A METAL SHARD WAS OBSERVED EXITING THE STAINLESS STEEL COOLING COIL OF THE CUSTOM PERFUSION TUBING SET DURING PRIMING. THE METAL SHARD WAS NOT ABLE TO BE LOCATED AFTER INITIAL OBSERVATION AND THE PACK WAS CHANGED OUT FOR THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Patient Involvement

    MAUDE report 7735139 ↗
  • MalfunctionJul 18, 2018Material Fragmentation; Material Fragmentation

    LIVANOVA RECEIVED A REPORT THAT A METAL SHAVING WAS OBSERVED IN THE POST-HEAT-EXCHANGER-COIL CARDIOPLEGIA TUBING OF THE CUSTOM PERFUSION TUBING SET. THIS WAS DISCOVERED DURING A PROCEDURE. THE SHAVING MADE ITS WAY TO THE RDC AND STAYED THERE. THE CUSTOMER OPENED A NEW PACK AND SET UP A NEW CARDIOPLEGIA CIRCUIT TO CONTINUE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7698169 ↗

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