S5 Console CP5 ConsoleRecalls & reported problems
LivaNova Deutschland GmbH · Class 2
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04033817903123), received between Oct 26, 2022 and Nov 14, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Pumping Stopped” (2 reports).
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
- Pumping Stopped2
- Decreased Pump Speed1
- Failure to Pump1
- Pumping Problem1
- Unexpected Shutdown1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 14, 2025Pumping Problem; Pumping Problem
SEE INITIAL REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23556377 ↗MalfunctionDec 7, 2023Decreased Pump Speed; Decreased Pump Speed
LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT DURING PROCEDURE SPEED OF A CP5 CONSOLE DROPPED TO 1000 RPM, WHICH IS THE MINIMUM THRESHOLD WITH NO ALARM SHOWING. SPEED WAS THEN TRIED TO BE INCREASED, HOWEVER THERE WAS NO RESPONSE FROM THE CP5 CONTROL PANEL. SYSTEM WAS REBOOTED AND THE ISSUE WAS STILL PRESENT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18281758 ↗MalfunctionApr 17, 2023Pumping Stopped; Unexpected Shutdown; Pumping Stopped; Unexpected Shutdown
SEE INITIAL REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16750551 ↗MalfunctionNov 22, 2022Pumping Stopped; Pumping Stopped
SEE INITIAL REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15843950 ↗MalfunctionOct 26, 2022Failure to Pump; Failure to Pump
LIVANOVA RECEIVED REPORT OF PUMP MOTOR HEAD MALFUNCTION ON A CP5 CONSOLE. THE ISSUE OCCURRED DURING SETUP AND THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15673235 ↗
Other CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS devices
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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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.