S5 Double Roller Pump 85 DRP 85 (UDI 04033817900405)Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 04033817900405), received between Jun 8, 2016 and Mar 17, 2026 — classified as 52 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (27 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 54 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2026Pumping Stopped

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT, DURING PROCEDURE, A S5 DOUBLE ROLLER PUMP HAD AN INTERNAL ALARM. THE MESSAGE DISPLAY READ "INTERNAL TEMPERATURE IS TOO HIGH". REPORTEDLY, PUMP WAS NOT ROTATING SMOOTHLY BUT JERKY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24616385 ↗
• MalfunctionMar 10, 2026Application Program Problem

  LIVANOVA DEUTSCHLAND HAS RECEIVED A REPORT CONCERNING AN ESSENZ HEART-LUNG MACHINE (HLM) COCKPIT THAT BRIEFLY BLACKED OUT AFTER THE PERFUSIONIST REVERSED THE PUMP DIRECTION DURING A PROCEDURE. NO PATIENT INJURY HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24556530 ↗
• MalfunctionFeb 27, 2026Pumping Problem

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24471746 ↗
• MalfunctionSep 3, 2025Failure to Auto Stop; Failure to Auto Stop

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22950145 ↗
• MalfunctionMay 7, 2025Pumping Stopped; Pumping Stopped

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT, DURING A PROCEDURE, THE S5 DOUBLE ROLLER PUMP 85 FAILED AND SHUT OFF 10 SECOND AFTER BEING TURNED ON (NO FLOW). THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21976561 ↗
• MalfunctionNov 29, 2024Pumping Problem; Pumping Problem

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20809263 ↗
• MalfunctionOct 9, 2024Pumping Stopped; Pumping Stopped

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A S5 DOUBLE ROLLER PUMP 85 HEAD MALFUNCTIONED WHEN IT WAS IN SERVICE. IT WAS THE BLOOD PUMP ON THE CARDIOPLEGIA DOUBLE HEADER. THE AFFECTED PUMP HAS BEEN REPLACED WITH A SPARE ONE. NO ADDITIONAL INFORMATION IS AVAILABLE SO FAR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20407313 ↗
• MalfunctionOct 9, 2024Pumping Stopped; Pumping Stopped

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A S5 DOUBLE ROLLER PUMP 85 HEAD MALFUNCTIONED WHEN IT WAS IN SERVICE. IT WAS THE BLOOD PUMP ON THE CARDIOPLEGIA DOUBLE HEADER. THE AFFECTED PUMP HAS BEEN REPLACED WITH A SPARE ONE. NO ADDITIONAL INFORMATION IS AVAILABLE SO FAR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20407264 ↗
• MalfunctionJul 8, 2024Pumping Stopped; Pumping Stopped

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A S5 DOUBLE HEAD PUMP GAVE A FAULT IN MOTOR CONTROLLER ERROR MESSAGE (CODE 442) DURING PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19687681 ↗
• MalfunctionJul 5, 2024Pumping Problem; Pumping Problem

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A S5 DOUBLE HEAD PUMP GAVE AN INTERMITTENT ERROR (ROTATION DETECTOR ERROR VALUE) DURING PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19678251 ↗
• MalfunctionMar 6, 2024Pumping Problem; Pumping Problem

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18844770 ↗
• MalfunctionJan 12, 2024Pumping Stopped; Pumping Stopped

  SEE INTIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18500849 ↗
• MalfunctionJul 27, 2023Pumping Stopped; Pumping Stopped

  SEE INITIAL REPORT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17404798 ↗
• MalfunctionMay 12, 2023Pumping Stopped; Pumping Stopped

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16917933 ↗
• MalfunctionApr 21, 2023Pumping Problem; Pumping Problem

  SEE INTIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16783509 ↗
• MalfunctionApr 5, 2023Pumping Stopped; Pumping Stopped

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16681784 ↗
• MalfunctionFeb 23, 2023Pumping Stopped; Pumping Problem; Pumping Stopped; Pumping Problem

  SEE INTIAL REPORT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16427044 ↗
• MalfunctionFeb 23, 2023Pumping Stopped; Pumping Problem; Pumping Stopped; Pumping Problem

  SEE INTIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16427041 ↗
• MalfunctionJan 19, 2023Pumping Stopped; Pumping Stopped

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16204963 ↗
• MalfunctionNov 23, 2022Pumping Stopped; Pumping Stopped

  LIVANOVA RECEIVED A REPORT THAT A S5 ROLLER PUMP GAVE A MOTOR CONTROL FAULT ERROR MESSAGE DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15852321 ↗
• MalfunctionOct 27, 2022Pumping Stopped; Pumping Stopped

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15679559 ↗
• MalfunctionOct 17, 2022Material Rupture; Material Rupture

  LIVANOVA RECEIVED REPORT THAT A S5 DOUBLE HEAD PUMP HAD A BLOOD LEAK DUE TO HEMOCON TUBE BREAKAGE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15615191 ↗
• MalfunctionOct 12, 2022Pumping Stopped; Pumping Stopped

  LIVANOVA RECEIVED REPORT THAT A S5 DOUBLE ROLLER PUMP GAVE A MOTOR CONTROL FAILURE ERROR MESSAGE DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15585429 ↗
• MalfunctionSep 2, 2022Pumping Stopped; Pumping Stopped

  LIVANOVA RECEIVED REPORT OF MULTIPLE MOTOR CONTROL FAILURE ERROR MESSAGES FOLLOWED BY ANOTHER MESSAGE ¿INTERNAL MALFUNCTION - REMAINS OPERATIONAL¿. THE S5 DOUBLE HEAD PUMP HAS BEEN TAKEN OUT OF SERVICE. REPORTEDLY, CARDIOPLEGIA PUMP STOPPED WORKING, AFTER SWITCHING PUMP OFF AND THEN ON AGAIN THE PUMP STARTED TO WORK AGAIN AS EXPECTED. THIS HAS HAPPENED ON A FEW OCCASIONS DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15347773 ↗
• MalfunctionAug 26, 2022Pumping Stopped; Pumping Stopped

  LIVANOVA RECEIVED REPORT THAT A S5 DOUBLE ROLLER PUMP GAVE A MOTOR CONTROL FAILURE ERROR MESSAGE DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15301061 ↗

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-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-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-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-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