Perfusion Pack (UDI 00803622140495)Recalls & reported problems

Data updated Oct 18, 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 00803622140495), received between Apr 23, 2020 and Apr 23, 2020 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

MalfunctionApr 23, 2020Disconnection; Disconnection
LIVANOVA USA INC HAS RECEIVED A REPORT THAT, UPON REWARMING DURING A PROCEDURE, THE TUBING WITH CONNECTS THE PUMP OUTLET WITH THE OXYGENATOR INLET DISCONNECTED BY THE OXYGENATOR SIDE. THE PERFUSIONIST PUSHED THE TUBING BACK ON THE OXYGENATOR INLET AND RECORDED THE CIRCUIT TO DE AIR AND RESUME BYPASS. APPROXIMATELY 600CC OF PATIENT BLOOD VOLUME WERE LOST AND MEDICAL TEAM ELECTED TO ADMINISTER 2 UNITS OF BLOOD BANK. THE PATIENT WAS EXTUBATED AND IS RECOVERING AS EXPECTED. THERE IS NO REPORT OF ANY PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9989291 ↗

Device details

UDI-DI	`00803622140495`
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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