S5 Console 5-position (UDI 04033817900900)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 04033817900900), received between Mar 20, 2018 and Feb 20, 2026 — classified as 2 deaths, 14 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (3 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2026Unstable

  see initial report.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24398519 ↗
• MalfunctionMay 31, 2025Low Readings; Low Readings

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22120428 ↗
• MalfunctionFeb 20, 2025Pumping Stopped; Pumping Stopped

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21421567 ↗
• DeathAug 26, 2024No Apparent Adverse Event; No Apparent Adverse Event

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT FROM AEMPS OF A DEATH CASE IN WHICH A S5 SYSTEM WAS USED. CUSTOMER HAS NOT NOTIFIED DIRECTLY LIVANOVA OF THE EVENT WHEN IT OCCURRED, AS HE DID NOT CONSIDER THE S5 DEVICE TO BE INVOLVED.

  Patient problems: Air Embolism

  MAUDE report 20065346 ↗
• MalfunctionJul 10, 2024Pumping Problem; Pumping Problem

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19708748 ↗
• MalfunctionJan 16, 2024Pumping Stopped; Pumping Stopped

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A S5 ROLLER PUMP GAVE A MOTOR CONTROL FAILURE ERROR MESSAGE DURING PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18516170 ↗
• MalfunctionNov 18, 2022Electrical Shorting; Electrical Shorting

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A S5 PUMP STARTED SMOKING DURING A CASE. SIMULTANEOUSLY, A ¿POP¿ WAS HEARD. THE PUMP TRANSITIONED TO BATTERY. THE PERFUSIONIST UNPLUGGED THE PUMP AND RAN ON BATTERY FOR THE REMAINDER OF THE CASE. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15824075 ↗
• DeathSep 2, 2022Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  LIVANOVA RECEIVED REPORT THAT A PATIENT WAS INJURED AND A S5 SYSTEM WAS USED. ACCORDING TO THE MANAGEMENT OF CARDIOTECHNOLOGY, THE TUBE WAS INSERTED IN THE WRONG DIRECTION AND AIR WAS PUMPED INTO THE PATIENT. THE PATIENT DIED. REPORTEDLY, THE MACHINE HAS BEEN TAKEN OUT OF SERVICE. NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND THE EVENT WERE PROVIDED.

  Patient problems: Air Embolism; Embolism/Embolus

  MAUDE report 15347776 ↗
• MalfunctionDec 17, 2021Failure to Auto Stop; Failure to Auto Stop

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13023921 ↗
• MalfunctionMay 7, 2019No Display/Image; No Display/Image

  LIVANOVA (B)(4) RECEIVED A REPORT THAT SEVERAL VALUES WHICH WERE DISPLAYED ON THE S5 SYSTEM SUDDENLY DISAPPEARED DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8585964 ↗
• MalfunctionApr 16, 2019Thermal Decomposition of Device; Appropriate Device Problem Term/Code Not Available; Thermal Decomposition of Device; Appropriate Device Problem Term/Code Not Available

  SEE INITIAL REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8517089 ↗
• MalfunctionMar 21, 2019Overheating of Device; Overheating of Device

  LIVANOVA (B)(4) RECEIVED A REPORT THAT A BURNING SMELL WAS NOTICED DURING THE USE OF A S5 SYSTEM. IT WAS FURTHER REPORTED THAT AFTER THE BURNING SMELL, AN ERROR MESSAGE WAS DISPLAYED ON THE S5 SYSTEM. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8439100 ↗
• MalfunctionNov 2, 2018Loss of Power; Loss of Power

  LIVANOVA (B)(4) RECEIVED A REPORT THAT A S5 SYSTEM STOPPED WORKING DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8031845 ↗
• MalfunctionJul 16, 2018No Display/Image; No Display/Image

  LIVANOVA (B)(4) RECEIVED A REPORT THAT A S5 SYSTEM PANEL DOES NOT POWER ON DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7688959 ↗
• MalfunctionMar 20, 2018No Display/Image; No Display/Image

  LIVANOVA (B)(4) RECEIVED A REPORT THAT A ALL DISPLAY AND CONTROL MODULES OF A S5 SYSTEM WENT BLANK DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7352402 ↗
• MalfunctionMar 20, 2018Thermal Decomposition of Device; Device Displays Incorrect Message; Thermal Decomposition of Device; Device Displays Incorrect Message

  LIVANOVA (B)(4) RECEIVED A REPORT THAT A S5 SYSTEM DISPLAYED AN ALARM AND THE CUSTOMER REPORTED BURNING SMELL AFTER THE ALARM OCCURRED DURING PROCEDURE. IN ADDITION THE BATTERY LEVEL INDICATOR AND PERCENTAGE BECAME BLANK THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7352385 ↗

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-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-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-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-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-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-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.
• 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-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