Perfusion Pack (UDI 00803622148637)Recalls & reported problems

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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 00803622148637), received between Mar 29, 2023 and Mar 29, 2023 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

Fluid/Blood Leak1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

MalfunctionMar 29, 2023Fluid/Blood Leak; Fluid/Blood Leak
LIVANOVA USA INC HAS RECEIVED REPORT THAT, AFTER ONE HOUR ON BYPASS, PATIENT BLOOD STARTED DRIPPING FROM A Y CONNECTOR. BLOOD FLOW AND PRESSURES INCREASED AND THE LEAK INCREASED. MEDICAL TEAM TIE BANDED THE CONNECTION AND ADDED BONE WAX. THE LEAK WAS NOT STOPPED. ACCORDING TO INFORMATION, 1800 ML OF PATIENT BLOOD WAS LOST. PATIENT WAS ADMINISTERED A UNIT OF BLOOD. THERE IS NO REPORT OF ANY PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16636432 ↗

Device details

UDI-DI	`00803622148637`
Brand	Perfusion Pack
Model	Perfusion Pack
Company	Livanova USA, Inc.
Product code	—
Class	—
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Dec 8, 2022

Device type (GMDN): Cardiopulmonary bypass system blood tubing set

A collection of sterile devices including tubing and typically clamps, filters, connectors, and stopcocks, used in a circuit for a cardiopulmonary bypass procedure. The tubing is typically polymeric and may be heparin coated. It is typically used in the blood pump head of a cardiopulmonary bypass system. The tubing, when used in a roller type pump, will be cyclically compressed by the blood pump to cause the blood to flow through the heart-lung bypass system. This is a single-use device.

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page