S5 Console 3-position (UDI 04033817902669)Recalls & reported problems

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 04033817902669), received between Dec 24, 2025 and Dec 24, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Pumping Stopped” (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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Pumping Stopped1

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.

MalfunctionDec 24, 2025Pumping Stopped; Pumping Stopped
LIVANOVA DEUTSCHLAND RECEIVED A REPORT OF AN S5 ROLLER PUMP MOTOR CONTROLLER ERROR. THE EVENT OCCURRED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23886995 ↗

Device details

UDI-DI	`04033817902669`
Brand	S5 Console
Model	3-position
Company	LivaNova Deutschland GmbH
Product code	DTQ · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
Class	Class 2
FDA submission	K210130
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	May 7, 2024

Device type (GMDN): Cardiopulmonary bypass system, roller type

An assembly of devices that provides mechanical circulatory support during open-heart surgery, bypassing the heart to facilitate surgery on the organ. The basic function of the machine is to oxygenate the body's venous supply of blood and then pump it back into the arterial circuit. It will typically provide intracardiac suction, filtration, and temperature control. This device typically consists of mains electricity (AC-powered) console with roller pumps, oxygenators, a heat exchanger, temperature regulators, a reservoir, filters, a defoamer, and a handcrank for manual emergency rotation of a blood pump. Some systems are manufactured as a single unit while others are made up of modules.

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All CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS devices →

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