S5 Roller Pump 150 RP 150 (UDI 04033817900382)Recalls & reported problems

Summary

The FDA's MAUDE database contains 120 adverse event reports that list this exact device (DI 04033817900382), received between Jul 26, 2016 and Feb 20, 2026 — classified as 1 death, 113 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (59 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 120 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2026Pumping Stopped

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT STATING THAT AN S5 HLM ROLLER PUMP 150 STOPPED RUNNING AFTER THE PROCEDURE. THE INVOLVED PUMP WAS USED AS AN AUXILIARY SUCTION PUMP. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24400592 ↗
• MalfunctionFeb 20, 2026Pumping Stopped

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT STATING THAT AN S5 HLM ROLLER PUMP 150 STOPPED RUNNING AND ITS DISPLAY WENT BLACK DURING THE PROCEDURE. THE INVOLVED PUMP WAS USED AS AN AUXILIARY SUCTION PUMP. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24399207 ↗
• MalfunctionJan 27, 2026Pumping Stopped

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT THE S5 HLM SHOWED THE ERROR MESSAGE MOTOR CONTROL FAILURE, RELATED TO ROLLER PUMP 1. THE ISSUE OCCURRED DURING PROCEDURE. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24186655 ↗
• MalfunctionDec 10, 2025Pumping Stopped; Pumping Stopped

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23767847 ↗
• MalfunctionSep 19, 2025Pumping Stopped; Pumping Stopped

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23097948 ↗
• MalfunctionSep 2, 2025Pumping Stopped; Pumping Stopped

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22931807 ↗
• MalfunctionAug 8, 2025Pumping Stopped; Pumping Stopped

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22747201 ↗
• MalfunctionJul 21, 2025Pumping Problem; Pumping Problem

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22561452 ↗
• MalfunctionJun 4, 2025Pumping Stopped; Pumping Stopped

  LIVANOVA RECEIVED REPORT THAT THE S5 ROLLER PUMP ALARMED MOTOR OVERSPEED, THEN SHOWED A FAULT IN THE MOTOR CONTROLLER (429), CAUSING THE PUMP HEAD TO STOP WORKING DURING USE, THERE WAS NO REPORT OF PATIENT INJURY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22139194 ↗
• MalfunctionMay 31, 2025Pumping Stopped; Pumping Stopped

  SEE INTIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22120448 ↗
• MalfunctionFeb 6, 2025Pumping Stopped; Pumping Stopped

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A S5 ROLLER PUMP 150 DISPLAYED A MOTOR CONTROL ERROR DURING A PROCEDURE. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21322630 ↗
• MalfunctionDec 27, 2024Pumping Problem; Pumping Problem

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21027764 ↗
• MalfunctionDec 3, 2024Pumping Stopped; Pumping Stopped

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20830138 ↗
• MalfunctionNov 13, 2024Unstable; Unstable

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20673690 ↗
• MalfunctionOct 25, 2024Unexpected Shutdown; Unexpected Shutdown

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT ROLLER HEAD PUMP SHUTTING OFF EVERY MIN WITHOUT ANY ALARM DURING A PROCEDURE. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20532444 ↗
• MalfunctionJul 9, 2024Pumping Stopped; Pumping Stopped

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A S5 ROLLER PUMP GAVE A MOTOR CONTROLLER ERROR MESSAGE (CODE 441) AND IT STARTED WORKING AGAIN WHEN THE MESSAGE WAS CLEARED. THE ISSUE OCCURRED DURING CLEANING, AFTER PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19699348 ↗
• MalfunctionMay 30, 2024Pumping Stopped; Pumping Stopped

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19423621 ↗
• MalfunctionMay 28, 2024Pumping Stopped; Pumping Stopped

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT, THE SINGLE ROLLER PUMP 150 DISPLAYED AN MOTOR CONTROL FAILURE ERROR (E#431) DURING INSTALLATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19403918 ↗
• MalfunctionMay 17, 2024Pumping Stopped; Pumping Stopped

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19340531 ↗
• MalfunctionApr 18, 2024Pumping Stopped; Pumping Stopped

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT , DURING INSTALLATION, THE S5 SINGLE ROLLER PUMP 150 PUMP STOPPED AND DISPLAYED ALARM WITH YELLOW TRIANGLE SHAPE INCLUDING EXCLAMATION MARK. NO OTHER ACTIVITY WAS POSSIBLE WHEN THE ALARM WAS DISPLAYED. AT THE TIME OF THE FIRST OCCURRENCE OF THE PROBLEM, THE MESSAGE 'MOTOR CONTROLLER FAILED PUMP 4' WAS DISPLAYED AND, AFTERWARD, THE MESSAGE WAS NOT LONGER DISPLAYED. ADDITIONAL TESTS FOUND THE PROBLEM RECURS INTERMITTENTLY REGARDLESS OF THE OPERATING STATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19131987 ↗
• MalfunctionApr 2, 2024Pumping Stopped; Pumping Stopped

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT POWER BUTTON OF A S5 ROLLER PUMP CAME OUT ON ITS OWN DURING PROCEDURE AND THEREFORE PUMP SHUT OFF. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19019118 ↗
• MalfunctionMar 15, 2024Pumping Stopped; Pumping Stopped

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A S5 ROLLER PUMP GAVE A MOTOR CONTROL FAILURE ERROR MESSAGE WHEN THE MACHINE WAS IN SERVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18910751 ↗
• MalfunctionMar 7, 2024Pumping Stopped; Pumping Stopped

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18855679 ↗
• MalfunctionJan 12, 2024Pumping Stopped; Pumping Stopped

  LIVANOVA DEUTSCHLAND HAS RECEIVED A REPORT THAT, DURING PERIODIC SERVICE MAINTENANCE, LIVANOVA WAS INFORMED THAT THE S5 ROLLER PUMP 150 DISPLAYED AGAIN FAULT IN MOTOR CONTROLLER (E433) AS PREVIOUSLY REPORTED IN 9611109-2023-00408 AND 9611109-2023-00626. LIVANOVA SERVICE WAS NOT SUCCESSFUL IN DUPLICATING THE ISSUE ANY TIME. SEVERAL COMPONENTS HAVE BEEN REPLACED AND CUSTOMER REPORTED THE ISSUE HAS OCCURRED A THIRD TIME. LIVANOVA HAS BEEN INFORMED THE MEDICAL TEAM SWITCHED THE PUMP ASSIGNMENT FROM CARDIOPLEGIA TO SUCKER AND THAT SINCE SWITCHING THEY HAVE NOT HAD THAT ISSUE AND NO FURTHER ALARM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18500788 ↗
• MalfunctionDec 11, 2023Pumping Stopped; Pumping Stopped

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18299155 ↗

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-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-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-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-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-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-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.