S5 ConsoleRecalls & reported problems across all models

We found 7 models of S5 Console by LivaNova Deutschland GmbH in the FDA's device registry (GUDID). Together they are named in 141 adverse event reports in the FDA's MAUDE database, received between Jul 20, 2016 and Mar 13, 2026 — classified as 3 deaths, 1 injury, 134 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (36 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported S5 Console problems

S5 Console models

7 models, most reported first. Each model has its own page with its reports, recalls and device details.

• S5 Console 4-position

  CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  1 death65 reports
• S5 Console 3-position

  CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  37 reports
• S5 Console 5-position

  CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  2 deaths16 reports
• S5 Console 4-position

  CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  15 reports
• S5 Console CP5 Console

  CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  5 reports
• S5 Console 5-position

  CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  2 reports
• S5 Console 3-position

  CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  1 report

Recent S5 Console adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2026Unstable

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT THE KNOB OF AN ARTERIAL PUMP OF AN S5 HEART-LUNG MACHINE (HLM) TURNED INCONSISTENTLY. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24598108 ↗
• MalfunctionMar 4, 2026Mechanical Jam

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24510882 ↗
• MalfunctionMar 4, 2026Pumping Problem

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24510619 ↗
• MalfunctionFeb 20, 2026Unstable

  see initial report.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24398519 ↗
• MalfunctionJan 22, 2026Pumping Problem

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT AN S5 HLM ROLLER PUMP WAS NOT FUNCTIONING. THE ISSUE OCCURRED DURING PROCEDURE THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24144350 ↗
• 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 ↗
• MalfunctionDec 23, 2025Unexpected Shutdown; Unexpected Shutdown

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT INDICATING THAT, DURING PROCEDURE, A CP5 CONSOLE ABRUPTLY POWERED OFF. REPORTEDLY, THE CONSOLE RESUMED NORMAL OPERATION AFTER BEING TURNED BACK ON. AS A PRECAUTIONARY MEASURE, ALL CONNECTING CABLES WERE DISCONNECTED AND RECONNECTED TO ENSURE THAT NO LOOSE CONNECTIONS WERE PRESENT. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23876372 ↗
• MalfunctionDec 19, 2025Use of Device Problem; Use of Device Problem

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23851728 ↗
• MalfunctionDec 3, 2025Difficult to Open or Close; Difficult to Open or Close

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT AN ERC CLAMP IN USE WITH A S5 HLM MACHINE WAS NOT OPERATING CORRECTLY, DURING PRIMING. THERE IS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23701990 ↗
• MalfunctionNov 26, 2025Pumping Problem; Pumping Problem

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT THE S5 HLM CARDIOPLEGIA PUMP WAS RUNNING SLOW. THE ISSUE OCCURRED DURING MAINTENANCE. THERE IS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23660181 ↗
• MalfunctionNov 25, 2025Pumping Problem; Pumping Problem

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23645249 ↗
• MalfunctionNov 14, 2025Pumping Problem; Pumping Problem

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23556377 ↗
• MalfunctionNov 7, 2025Low Readings; Low Readings

  LIVANOVA DEUTSCHLAND RECEIVED REPORT OF A DEFECTIVE BUBBLE SENSOR, DETECTING BUBBLES INTERMITTENTLY, WITH ERROR MESSAGE DISPLAYED ONTO THE UNIT. REPORTEDLY, ALL CONNECTIONS AND BUBBLE MODULE WERE CHECKED WITH NO ISSUE. EVEN INSTALLING THE SENSOR ON ANOTHER HLM MACHINE, THE PROBLEM PERSISTED. THE EVENT OCCURRED DURING PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23496794 ↗
• MalfunctionSep 18, 2025Pumping Stopped; Pumping Stopped

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23085523 ↗
• MalfunctionSep 2, 2025Increased Pump Speed; Mechanics Altered; Increased Pump Speed; Mechanics Altered

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22931867 ↗

Other LivaNova Deutschland GmbH products

• Heater-Cooler System2 models · 311 reports · 1 recall
• ESSENZ8 models · 185 reports · 1 recall
• CP54 models · 96 reports · 1 recall
• S5 Roller Pump 1502 models · 135 reports
• Electronic Gas Blender3 models · 106 reports
• Electrical Remote-Controlled Tubing Clamp3 models · 85 reports
• S5 Double Roller Pump 852 models · 59 reports
• S5 Mast Roller Pump4 models · 47 reports