S5 Console 3-position (UDI 04033817900887)Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 04033817900887), received between Jul 20, 2016 and Mar 13, 2026 — classified as 35 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (8 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 37 reports, 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionJun 4, 2025Difficult to Open or Close; Difficult to Open or Close

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT AN ELECTRICAL REMOTE-CONTROLLED TUBING CLAMP (ERC) OF AN S5 SYSTEM GAVE AN ERROR MESSAGE DURING PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22139553 ↗
• MalfunctionMay 20, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT THE ROLLER PUMP 150 IS HAVING INTERMITTENT ISSUES SWITCHING ON/OFF. MEDICAL TEAM OPTED FOR HAND CRANK. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22050378 ↗
• MalfunctionMay 7, 2025Pumping Problem; Pumping Problem

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A S5 SYSTEM GAVE AN ALARM (ERROR CODE UNKNOWN) THAT WAS GOING OFF INTERMITTENTLY. THE ISSUE OCCURRED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21976442 ↗
• MalfunctionApr 17, 2025Pumping Stopped; Pumping Stopped

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT S5 CONSOLE DISPLAYED FAULT ERROR DURING A PROCEDURE. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21857613 ↗
• MalfunctionDec 10, 2024Pumping Problem; Pumping Problem

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A S5 CONSOLE GAVE AN ALARM/ERROR MESSAGE DURING PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20889863 ↗
• MalfunctionDec 5, 2024Pumping Stopped; Pumping Stopped

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT THE DISPLAY MODULE ON A S5 CONSOLE DISPLAYED ERROR FAULT IN MOTOR CONTROLLER PUMP 2A DURING A PROCEDURE. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20851522 ↗
• MalfunctionNov 6, 2024False Alarm; Low Readings; False Alarm; Low Readings

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20618783 ↗
• MalfunctionJul 23, 2024Pumping Stopped; Pumping Stopped

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19803408 ↗
• MalfunctionMar 27, 2024Pumping Problem; Pumping Problem

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18984912 ↗
• MalfunctionJan 12, 2024No Audible Alarm; No Audible Prompt/Feedback; No Audible Alarm; No Audible Prompt/Feedback

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18500787 ↗
• MalfunctionApr 19, 2023Difficult to Open or Close; Difficult to Open or Close

  LIVANOVA DEUTSCHLAND HAS RECEIVED A REPORT OF A SCP ELECTRICAL REMOTE-CONTROLLED TUBING CLAMP 500MM NOT WORKING DURING A PROCEDURE. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16767216 ↗
• MalfunctionApr 5, 2023Failure to Auto Stop; Failure to Auto Stop

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT DURING PROCEDURE A S5 ROLLER PUMP DID NOT STOP AFTER THE LIQUID PASSED THROUGH THE BUBBLE SENSOR; THE USER DID NOT SEE ANY VISUAL OR AUDIBLE ALARM. THE CIRCUIT USED BY THE CUSTOMER INCLUDES AN AIR PURGE CONTROL (APC) FILTER UTILIZED WITH A SERVO DRIVE ON A S5 ROLLER PUMP AND A 3/8" BUBBLE SENSOR. THE S5 SYSTEM WAS LINKED TO A CENTRIFUGAL PUMP SYSTEM (SCP). THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16681778 ↗
• MalfunctionDec 14, 2022Pumping Stopped; Pumping Stopped

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A S5 CONSOLE PRESENTED ERROR FAULT IN MOTOR CONTROLLER (429) IN PUMP 2 DURING A PROCEDURE. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15975387 ↗
• MalfunctionAug 12, 2022Electrical Shorting; Electrical Shorting

  LIVANOVA RECEIVED REPORT THAT THE AC POWER SUPPLY OF THE OPERATING ROOM TRIPPED AND WOULD TRIP EVERY TIME WHEN THE S5-CP5 MACHINE WAS PLUGGED IN. THERE WAS NO PATIENT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15215668 ↗
• MalfunctionJul 11, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  LIVANOVA (B)(4) RECEIVED A REPORT THAT A S5 SYSTEM DISPLAYED AN ERROR MESSAGE DURING PROCEDURE. THE ERROR CODE IS STATING A FAULT IN THE MOTOR CONTROLLER OF THE PUMP. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Patient Involvement

  MAUDE report 8780506 ↗
• MalfunctionJul 4, 2019Image Display Error/Artifact; Image Display Error/Artifact

  LIVANOVA (B)(4) RECEIVED A REPORT THAT A S5 SYSTEM SHOWED A SHORT-TERM INTERNAL MALFUNCTION, BUT IT REMAINED OPERATIONAL. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8762342 ↗
• MalfunctionJun 21, 2019No Flow; No Flow

  SEE INITIAL REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8721192 ↗
• MalfunctionDec 6, 2018Device Alarm System; Pumping Stopped; Device Alarm System; Pumping Stopped

  LIVANOVA (B)(4) RECEIVED A REPORT THAT A S5 SYSTEM ALARMED WITHOUT WARNING MASSAGES AND THAT A PUMP STOPPED DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8137172 ↗
• MalfunctionAug 7, 2018Electrical Power Problem; Electrical Power Problem

  LIVANOVA (B)(4) RECEIVED A REPORT THAT A CIRCUIT BREAKER WAS TRIPPED AND THE S5 SYSTEM STOPPED WORKING DUE TO THIS DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7756040 ↗
• MalfunctionMay 4, 2018No Display/Image; No Display/Image

  LIVANOVA (B)(4) RECEIVED A REPORT THAT ON A S5 SYSTEM THE DISPLAY LOCKS UP INTERMITTENTLY DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7485966 ↗
• MalfunctionApr 27, 2018No Display/Image; No Display/Image

  LIVANOVA (B)(4) RECEIVED A REPORT THAT ON A S5 SYSTEM THE DISPLAY LOCKS UP INTERMITTENTLY DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7468133 ↗
• MalfunctionApr 26, 2018No Display/Image; No Display/Image

  LIVANOVA (B)(4) RECEIVED A REPORT THAT THE TOUCH SCREEN OF AN S5 SYSTEM BECAME UNRESPONSIVE DURING A PROCEDURE. THE USER ALSO REPORTED THAT THE PUMP STOPPED. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7466897 ↗

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-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-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-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-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-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.