Perfusion Pack (UDI 00803622135941)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00803622135941), received between Jul 8, 2022 and Aug 5, 2022 — classified as 1 injury, 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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 5, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ON JULY 12, 2022, LIVANOVA RECEIVED THE MEDWATCH MW5110693 STATING ¿EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) CANNULA PIGTAIL FAILED AND "POPPED OFF" RESULTING IN APPROXIMATELY 2 LITER BLOOD LOSS REQUIRING MASSIVE TRANSFUSION PROTOCOL TO BE ACTIVATED. PIGTAIL FOUND TO BE DEFECTIVE AND DESCRIBED AS "SHREDDED".

  Patient problems: Hypovolemia

  MAUDE report 15173624 ↗
• MalfunctionJul 8, 2022Disconnection; Disconnection

  LIVANOVA USA RECEIVED A REPORT THAT AFTER 15 DAYS ECMO SUPPORT, THE CONNECTOR HOOKED UP TO A DISTAL PERFUSION CATHETER (MALE END ATTACHES TO AN ARTERIAL CANNULA AND THE STOPCOCK PORTION ATTACHES TO A DISTAL PERFUSION CATHETER) DISCONNECTED. PATIENT LOST APPROXIMATELY ONE LITER OF BLOOD. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: Hypovolemia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14955283 ↗