S5 Console 4-position (UDI 04033817902676)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 04033817902676), received between May 18, 2022 and Dec 3, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (9 reports).

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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2025Difficult to Open or Close; Difficult to Open or Close

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT AN ERC CLAMP IN USE WITH A S5 HLM MACHINE WAS NOT OPERATING CORRECTLY, DURING PRIMING. THERE IS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23701990 ↗
• MalfunctionSep 18, 2025Pumping Stopped; Pumping Stopped

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23085523 ↗
• MalfunctionSep 2, 2025Increased Pump Speed; Mechanics Altered; Increased Pump Speed; Mechanics Altered

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22931867 ↗
• MalfunctionAug 18, 2025Pumping Stopped; Pumping Stopped

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22826538 ↗
• MalfunctionJul 30, 2025Decreased Pump Speed; Appropriate Device Problem Term/Code Not Available; Decreased Pump Speed; Appropriate Device Problem Term/Code Not Available

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22662659 ↗
• MalfunctionJul 10, 2025Pumping Stopped; Pumping Stopped

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A S5 PUMP GAVE A MOTOR CONTROLLER FAULT ERROR MESSAGE (442 CODE) DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22466543 ↗
• MalfunctionMay 15, 2025Pumping Problem; Pumping Problem

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22025614 ↗
• MalfunctionMay 8, 2025Low Readings; Low Readings

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT OF BUBBLE DETECTOR ISSUES DURING A PROCEDURE. CUSTOMER REPORTED THAT IS LIKELY A SOFTWARE ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21984687 ↗
• MalfunctionOct 31, 2024Pumping Stopped; Pumping Stopped

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT, DURING PRIMING, THE S5 SINGLE ROLLER PUMP 150 DISPLAYED MOTOR CONTROL FAILED ERROR (E432). THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20578154 ↗
• MalfunctionJul 11, 2024Pumping Stopped; Pumping Stopped

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A SORIN S5 SYSTEM DISPLAYED ERROR FAULT IN MOTOR CONTROLLER 431 PUMP 5B DURING SET UP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19718621 ↗
• MalfunctionApr 18, 2024Pumping Stopped; Pumping Stopped

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT, DURING A PROCEDURE, AN ERROR WAS DISPLAYED BY THE CARDIOPLEGIA PUMP AND COULD NOT RUN. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19132097 ↗
• MalfunctionMar 27, 2024Pumping Problem; Pumping Problem

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A S5 PUMP GAVE A 'MOTOR MONITORING /CONTROL FAILED' ERROR MESSAGE DURING PROCEDURE. PUMP WAS WORKING AND THE CUSTOMER COULD CLEAR THE ERROR MESSAGE, BUT IT RETURNED EVERY 15 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18986325 ↗
• MalfunctionFeb 8, 2023Pumping Stopped; Pumping Stopped

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT THE CONTROL PANEL OF THE MAST PUMP ON THE HEART-LUNG MACHINE DISPLAYS AN ERROR MESSAGE DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16320410 ↗
• MalfunctionNov 4, 2022Pumping Stopped; Pumping Stopped

  LIVANOVA RECEIVED REPORT THAT THE CENTRIFUGAL PUMP 5 (CP5) SWITCHED OFF AND SWITCHED ON AGAIN AUTONOMOUSLY SIGNALING (TEMPORARY INTERNAL FAULT REUSE OF CENTRAL PUMP 1). SHORTLY AFTER BOTH ON THE SINGLE ROLLER PUMP AND THE DOUBLE ROLLER PUMP USED ON THE SAME S5 SYSTEM, A MOTOR CONTROL FAULT ERROR MESSAGE APPEARED. THE MACHINE WAS REPLACED. REPORTEDLY THE EQUIPOTENTIAL CABLE WAS IN USE. THE EVENT OCCURRED DURING DE-BUBBLING OF THE CIRCUIT AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15729025 ↗
• MalfunctionMay 18, 2022Pumping Stopped; Pumping Stopped

  LIVANOVA RECEIVED REPORT THAT WHEN SWITCHING ON THE S5 SYSTEM AFTER FEW MINUTES, A PUMP GAVE AN ERROR MESSAGE ASSOCIATED TO A SHAFT ENCODER FAULT. REPORTEDLY, THE ERROR MESSAGE WAS COMING CONTINUOUSLY AND PUMP WAS NOT RUNNING. THE CONNECTIONS WERE CHECKED AND REINSERT BUT THE PROBLEM PERSISTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14432973 ↗