S5 Console 5-position (UDI 04033817902683)Recalls & reported problems
LivaNova Deutschland GmbH · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04033817902683), received between Nov 8, 2024 and Mar 13, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Recalibrate” (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
Most reported problems
Device problems
- Failure to Recalibrate1
- Pumping Stopped1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 13, 2025Pumping Stopped; Pumping Stopped
LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A S5 PUMP GAVE A MOTOR CONTROLLER ERROR MESSAGE (CODE 442) AND AORTIC ROOT FAULT. THE ISSUE OCCURRED DURING PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21591742 ↗MalfunctionNov 8, 2024Failure to Recalibrate; Failure to Recalibrate
LIVANOVA DEUTSCHLAND RECEIVED A REPORT OF S5 BUBBLE SENSOR ISSUE DURING SET UP.THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20638953 ↗
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- Terumo® Advanced Perfusion System 1 816300Terumo Cardiovascular Systems Corporation · Console, Heart-Lung Machine, Cardiopulmonary Bypass300 reports
- Terumo® Advanced Perfusion System 1 816571Terumo Cardiovascular Systems Corporation · Console, Heart-Lung Machine, Cardiopulmonary Bypass230 reports
- Terumo® Advanced Perfusion System 1 801763Terumo Cardiovascular Systems Corporation · Console, Heart-Lung Machine, Cardiopulmonary Bypass1 death230 reports
- ESSENZ HLMLivaNova Deutschland GmbH · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS1 recall1 death110 reports
- Terumo® Advanced Perfusion System 1 5773Terumo Cardiovascular Systems Corporation · Console, Heart-Lung Machine, Cardiopulmonary Bypass1 recall78 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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