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S5 Roller Pump 150 RP 150 (UDI 04033817902713)Recalls & reported problems

LivaNova Deutschland GmbH · Class 2

All models of S5 Roller Pump 150 (2)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
15
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 04033817902713), received between Jul 7, 2022 and Oct 17, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (8 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 1 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 2 reportsSep 2024: 1 reportsOct 2024: 1 reportsNov 2024: 1 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 1 reportsMar 2025: 0 reportsApr 2025: 1 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 1 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Pumping Stopped8
  • Pumping Problem3
  • Failure to Auto Stop2
  • Appropriate Device Problem Term/Code Not Available1
  • Failure to Pump1
  • Increased Pump Speed1
  • Intermittent Loss of Power1
  • Unexpected Shutdown1

Patient problems

  • No Clinical Signs, Symptoms or Conditions14
  • Brain Injury1
  • Cerebral Edema1
  • Loss of consciousness1

Recent adverse event reports

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

  • MalfunctionOct 17, 2025Pumping Stopped; Appropriate Device Problem Term/Code Not Available; Pumping Stopped; Appropriate Device Problem Term/Code Not Available

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT, THE S5 SINGLE ROLLER PUMP 150 DISPLAYED ERROR MOTOR CONTROL FAILURE (E441) AND THE SCREEN TEMPORARILY BECAME BLACK. THE ISSUE OCCURRED DURING PROCEDURE. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23325595 ↗
  • MalfunctionApr 3, 2025Intermittent Loss of Power; Intermittent Loss of Power

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT, DURING A PROCEDURE, THE S5 ROLLER PUMP 150 HAD INTERMITTENT POWER ISSUE. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21762428 ↗
  • MalfunctionFeb 20, 2025Pumping Stopped; Pumping Stopped

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A S5 ROLLER PUMP 150 GAVE A RUNAWAY ERROR MESSAGE ("THE PUMP RAN TOO FAST: SET VALUE DIFFERENT TO ACTUAL VALUE") AND STOPPED WORKING. THE ISSUE OCCURRED DURING PROCEDURE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21419256 ↗
  • MalfunctionNov 22, 2024Pumping Problem; Pumping Problem

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A S5 ROLLER PUMP 150 GAVE A MOTOR CONTROLLER ERROR MESSAGE (ERROR CODE 432) AND A WHISTLE WAS HEARD BY THE USER COMING FROM THE PUMP MODULE. BY TURNING OFF THE MODULE AND TURNING IT BACK ON THE ERROR REMAINED. THE ISSUE OCCURRED POST-PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20756856 ↗
  • MalfunctionOct 25, 2024Pumping Stopped; Pumping Stopped

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT, DURING CHECK LIST OF THE HLM AND PRIME PROCEDURE, THE ROLLER PUMP 150 DISPLAYED AN ERROR RELATED TO FAILURE OF THE MOTOR CONTROL (E431). PERFUSIONIST TRIED TO SOLVE RESETTING THE PUMP. THE ISSUE APPERARED SOME MINUTES AFTER RESTART.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20531994 ↗
  • MalfunctionSep 10, 2024Pumping Problem; Pumping Problem

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A S5 ROLLER PUMP 150 HAD SOME DIFFICULTIES TO ROTATE SMOOTHLY AND WITH NO NOISE. SOME RESISTANCE/FRICTION WAS ALSO PRESENT WHEN TRYING TO OPERATE THE PUMP MANUALLY. THE ISSUE OCCURRED DURING MAINTENANCE ACTIVITY. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20178090 ↗
  • MalfunctionAug 23, 2024Pumping Stopped; Pumping Stopped

    SEE INITIAL REPORT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20047091 ↗
  • MalfunctionAug 7, 2024Increased Pump Speed; Increased Pump Speed

    SEE INITIAL REPORT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19928507 ↗
  • MalfunctionDec 22, 2023Pumping Stopped; Pumping Stopped

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A S5 ROLLER PUMP DID NOT RUN SMOOTHLY. THE ISSUE OCCURRED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18381746 ↗
  • MalfunctionMar 16, 2023Pumping Stopped; Pumping Stopped

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A S5 ROLLER PUMP PRO GAVE TWO MOTOR CONTROL FAILURE ERROR MESSAGES AT SETUP. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16551468 ↗
  • MalfunctionFeb 16, 2023Pumping Stopped; Pumping Problem; Pumping Stopped; Pumping Problem

    SEE INITIAL REPORT

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16384949 ↗
  • MalfunctionNov 17, 2022Failure to Pump; Failure to Auto Stop; Failure to Pump; Failure to Auto Stop

    LIVANOVA DEUTSCHLAND RECEIVED REPORT THAT THE ARTERIAL PUMP EXPERIENCED A PUMP CREEP. IN DETAILS, WHEN THE FLOW WAS STOPPED USING THE SPEED CONTROL KNOB, IT WOULD STOP BUT THEN, AFTER A COUPLE OF SECONDS, THE FLOW WOULD START BACK UP AT A VERY LOW FLOW RATE (0.1-0.3LPM). THIS HAPPENED REPEATEDLY DURING A CASE (WITH NO NEGATIVE EFFECT). THE PUMP WAS TAKEN OUT OF SERVICE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15814623 ↗
  • MalfunctionNov 10, 2022Pumping Stopped; Pumping Stopped

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A S5 DEVICE DISPLAYED E 431 (431 FAULT MOTOR CONTROL PUMP) DURING INSTALLATION. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15770165 ↗
  • MalfunctionSep 30, 2022Unexpected Shutdown; Unexpected Shutdown

    LIVANOVA RECEIVED REPORT THAT DURING CPB (ON MIN. 160) MAIN ARTERIAL PUMP STOPPED (FULL SHUTDOWN); CUSTOMER TRIED TO SWITCH ON SWITCH OFF PUMP COUPLE TIME WITHOUT SUCCESS AND HAND CRANK WAS PERFORMED. THE PATIENT CONDITION IS EXTREMELY SEVERE, UNCONSCIOUSNESS, EXTENSIVE ISCHEMIC BRAIN DAMAGE, CEREBRAL EDEMA, TRIPLEGIA.

    Patient problems: Brain Injury; Cerebral Edema; Loss of consciousness

    MAUDE report 15518689 ↗
  • MalfunctionJul 7, 2022Failure to Auto Stop; Failure to Auto Stop

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A S5 ROLLER PUMP HAD INTERMITTENT CREEP WHEN SET AT 0.00 LPM/0 RPM. THERE WAS NO REPORT IF PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14942549 ↗

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Sources and updates

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