S5 Console 4-position (UDI 04033817900894)Recalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 04033817900894), received between Oct 13, 2016 and Mar 4, 2026 — classified as 1 death, 1 injury, 62 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (15 reports).

13 other recalls cover devices cleared under the same FDA submission (K071318); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 65 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 19, 2025Use of Device Problem; Use of Device Problem

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23851728 ↗
• MalfunctionNov 25, 2025Pumping Problem; Pumping Problem

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23645249 ↗
• 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 ↗
• MalfunctionAug 6, 2025Unexpected Shutdown; Unexpected Shutdown

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A S5 CONSOLE SWITCHED OFF SUDDENLY DURING THE PRIMING SET UP. AFTER SOMETIMES THE MACHINE WAS POWERED ON BUT IT WAS NOT WORKING ON MAINS POWER SUPPLY. WHILE RUNNING ON BATTERY THE CHARGING % WAS ALSO NOT SHOWING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22726493 ↗
• MalfunctionAug 5, 2025Pumping Stopped; Pumping Stopped

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A S5 SYSTEM WAS DEFECTIVE DURING PRIMING. NO FURTHER INFORMATION IS AVAILABLE AT THE MOMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22714401 ↗
• MalfunctionJul 10, 2025Difficult to Open or Close; Difficult to Open or Close

  LIVANOVA DEUTSCHLAND HAS RECEIVED A REPORT THAT, THE S5 HLM DISPLAYED A DEFECTIVE ARTERIAL CLAMP ALARM THAT CANNOT BE CLEARED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22468412 ↗
• MalfunctionJul 8, 2025Pumping Problem; Pumping Problem

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT RELATED TO A S5 CONSOLE. WHEN ON PUMP WITH THE ARTERIAL LINE CLAMPLED, USER WAS LOSING VOLUME AND THERE WAS NO LEAK. THEREFORE, PERFUSIONIST TOOK OFF BYPASS AND CHANGED DISPOSABLES. NO CHANGE OCCURRED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22434692 ↗
• MalfunctionJun 20, 2025Pumping Stopped; Pumping Stopped

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT, DURING PROCEDURE, THE S5 ROLLER PUMPS USED AS ASPIRATORS TURNED OFF AND BACK ON SEVERAL TIMES, NOT SIMULTANEOUSLY, WITH THE CONSEQUENT PUMP STOP. THE CP5 DRIVER USED ON THE S5 SYSTEM AS ARTERIAL PUMP DID NOT RESPOND TO THE SET PRESSURE THRESHOLD, MAKING IT IMPOSSIBLE TO USE THE AUTOMATIC FLOW REGULATION FUNCTION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22298910 ↗
• MalfunctionJun 5, 2025Difficult to Open or Close; Difficult to Open or Close

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT AN OCCLUDER MOUNTED ON A S5 CONSOLE GAVE AN ERROR MESSAGE DURING PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE AT THE MOMENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22147830 ↗
• MalfunctionMay 26, 2025Complete Loss of Power; Complete Loss of Power

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22084732 ↗
• MalfunctionMay 15, 2025Restricted Flow rate; Use of Device Problem; Restricted Flow rate; Use of Device Problem

  SEE INITIAL REPORT.

  Patient problems: Insufficient Information

  MAUDE report 22025592 ↗
• InjuryMay 15, 2025Restricted Flow rate; Restricted Flow rate

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A CENTRIFUGAL PUMP (CP5) USED ON THE S5 SYSTEM SLOWED DOWN DUE TO A BIG BLOOD CLOT PRESENT INSIDE THE REVOLUTION HEAD, DURING PROCEDURE. MEDICAL TEAM THEN ELECTED TO SWITCH THE PATIENT TO ANOTHER S5 SYSTEM. REPORTEDLY, THE PATIENT OUTCOME DOES NOT LOOK GOOD. NO ADDITIONAL DETAILS ON PATIENT CONDITIONS WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22025557 ↗
• MalfunctionDec 2, 2024Difficult to Open or Close; Difficult to Open or Close

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20818160 ↗
• MalfunctionNov 7, 2024Unexpected Shutdown; Unexpected Shutdown

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20628688 ↗
• MalfunctionOct 28, 2024Pumping Stopped; Pumping Stopped

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A S5 PUMP STOPPED FUNCTIONING WITHOUT TRIGGERING ANY ALARM ALERTS. THE ISSUE OCCURRED DURING A PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20544702 ↗
• MalfunctionOct 18, 2024Pumping Stopped; Pumping Stopped

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT, DURING A PROCEDURE, THREE (3) DIFFERENT ROLLER PUMPS USED AS SUCKER DISPLAYED MOTOR CONTROL ERROR (E441). THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20480318 ↗
• MalfunctionOct 4, 2024Pumping Stopped; Pumping Stopped

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20366102 ↗
• MalfunctionSep 12, 2024Electrical Shorting; Electrical Shorting

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT WHEN THE SORIN S5 SYSTEM IS PLUGGED IN, IT TRIGGER THE OPERATION ROOM ALARM. THE ISSUE OCCURRED DURING MAINTENANCE AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20201489 ↗
• MalfunctionAug 21, 2024Pumping Problem; Pumping Problem

  LIVANOVA RECEIVED A REPORT ABOUT A PUMP ALARM "FAULT IN MOTOR CONTROLLER (431)". EVEN AFTER SWITCHING OFF/ON MULTIPLE TIMES - PUMP NOT REVOLVING. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20023638 ↗
• MalfunctionJun 18, 2024Defective Alarm; Defective Alarm

  LIVANOVA DEUTSCHLAND HAS RECEIVED A REPORT THAT A S5 PUMP DISPLAYED AN ERROR RELATED TO ENCODER MALFUNCTION. THE EVENT OCCURRED DURING A PROCEDURE. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19557045 ↗
• MalfunctionMay 7, 2024Pumping Problem; Pumping Problem

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19257353 ↗
• MalfunctionMay 6, 2024Pumping Stopped; Pumping Stopped

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT THE S5 CONSOLE FOR 4 PUMP WAS NOT WORKING PROPERLY DURING SET UP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19246684 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071318. One submission often covers many models, so check the product and lot details in each record.

• Z-1119-2020 · Jan 28, 2019 · Terminated
  LivaNova Sorin Connect DPIII KOMPL. S5 REF 96-415-130, 2017-08-15, IPX1, RXOnly, (01)04033817901594 Product Usage: The S5 System is used to perform, control and monitor extracorp
• Z-2866-2016 · Aug 25, 2016 · Terminated
  Stckert S5 System, S5 Heart-lung machine, Cardiopulmonary bypass heart-lung machine console Product Usage: The Stckert S5 System is intended to be used during cardiopulmonary bypa
• Z-0856-2014 · Dec 4, 2013 · Terminated
  S5/C5 Heart-lung machine Product Usage: The StOckert S5/ Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.
• Z-0142-2014 · Sep 24, 2013 · Terminated
  S5 Heart-lung machine, Stockert S5 System. Catalogue No: 48-30/40/50-00. The Stockert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six(6)
• Z-0274-2013 · Sep 19, 2012 · Terminated
  S5 Mast Roller Pump 150, Item Number: 10-88-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
• Z-0275-2013 · Sep 19, 2012 · Terminated
  Sorin C5 Perfusion System, Item number 58-00-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
• Z-0273-2013 · Sep 19, 2012 · Terminated
  S5 Mast Roller Pump 85, Item Number: 10-88-60 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
• Z-0271-2013 · Sep 19, 2012 · Terminated
  S5 Single Roller Pump 150, Item Number: 10-80-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
• Z-0272-2013 · Sep 19, 2012 · Terminated
  S5 Double Roller Pump 85, Item Number: 10-85-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
• Z-1327-2012 · Feb 23, 2012 · Terminated
  Control panel for mast roller pump 150/85 The S5 Perfusion System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six (6) ho
• Z-1328-2012 · Feb 23, 2012 · Terminated
  Control panel for mast roller pump 85 The S5 Perfusion System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six (6) hours.
• Z-1326-2012 · Feb 23, 2012 · Terminated
  S5 Double Roller Pump 85 The S5 Perfusion System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six (6) hours.
• Z-1325-2012 · Feb 23, 2012 · Terminated
  S5 Single Roller Pump 150 The S5 Perfusion System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six (6) hours.