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S5 Mast Roller Pump MRP 150Recalls & reported problems

LivaNova Deutschland GmbH · Class 2

Quick summary

This LivaNova S5 roller pump is used in heart-lung machines during cardiopulmonary bypass. There are 25 reports on file, and nearly all describe the pump stopping or running with problems — grinding noises, motor control errors, and cases where staff had to hand-crank it to keep blood flowing. No deaths are reported; one report mentions a brain injury. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
23
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 04033817900474), received between Aug 1, 2017 and Mar 30, 2026 — classified as 1 injury, 22 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (17 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 3 reportsJan 2024: 1 reportsFeb 2024: 0 reportsMar 2024: 1 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 2 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 2 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 1 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 1 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Pumping Stopped17
  • Pumping Problem2
  • Appropriate Device Problem Term/Code Not Available1
  • Decreased Pump Speed1
  • Display or Visual Feedback Problem1
  • Failure to Auto Stop1

Patient problems

  • No Clinical Signs, Symptoms or Conditions19
  • No Consequences Or Impact To Patient2
  • Brain Injury1
  • No Patient Involvement1

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 30, 2026Pumping Stopped

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT THE PUMP HEAD OF AN S5 MAST ROLLER PUMP 150 WAS NOT ROTATING SMOOTHLY AND WAS FREQUENTLY GIVING MESSAGE "MAXIMUM LOAD LIMIT IS REACHED" DURING PRIMING. THERE WAS NO PATIENT IMPACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24710692 ↗
  • MalfunctionAug 8, 2025Pumping Stopped; Pumping Stopped

    SEE INITIAL REPORT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22751628 ↗
  • MalfunctionOct 11, 2024Pumping Stopped; Pumping Stopped

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT, WHEN SWITCHING ON THE S5 SYSTEM, MASTER PUMP ALARM FAULT IN THE MOTOR CONTROL (429). THERE IS NO REPORT OF ANY PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20426232 ↗
  • MalfunctionOct 10, 2024Pumping Stopped; Pumping Stopped

    SEE INITIAL REPORT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20415953 ↗
  • MalfunctionJul 22, 2024Failure to Auto Stop; Failure to Auto Stop

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT ARTERIAL PUMP DID NOT STOP, DESPITE BEING SELECTED AS CONTROLLED PUMP, WHEN HIGH ARTERIAL PRESSURE ALARM WAS CREATED. NO ADDITIONAL INFORMATION WAS RECEIVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19790300 ↗
  • MalfunctionJul 9, 2024Pumping Stopped; Pumping Stopped

    SEE INITIAL REPORT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19701189 ↗
  • MalfunctionMar 22, 2024Pumping Stopped; Pumping Stopped

    SEE INITIAL REPORT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18957688 ↗
  • MalfunctionJan 15, 2024Pumping Stopped; Pumping Stopped

    SEE INITIAL REPORT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18510417 ↗
  • MalfunctionDec 28, 2023Pumping Stopped; Pumping Stopped

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A S5 MAST ROLLER PUMP STOPPED DURING THE CASE AND THERE WAS NO ALARM, EITHER AUDIBLE OR VISUAL. CUSTOMER TRIED TO RESTART THE PUMP WITHOUT SUCCESS, THEREFORE HAND CRANK WAS STARTED; NORMAL ALARMS OF RUNAWAY MOTOR DUE TO HAND CRANKING APPEARED. THE PUMP WAS THEN TURNED OFF AND ON AGAIN AND STOPPED HAND CRANKING: THE VALUE ON THE SCREEN WENT UP, BUT THE PUMP DIDN'T TURN. CUSTOMER BELIEVED TO HAVE THE PUMP LID OVERRIDDEN AT THIS POINT, HOWEVER NO ALARM WAS WORKING ON THE INVOLVED ARTERIAL PUMP. LASTLY, THE AFFECTED PUMP WAS CHANGED WITH A CENTRIFUGAL ONE AND EVERYTHING STARTED AGAIN. SURGERY WAS COMPLETED WITH NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18407711 ↗
  • MalfunctionDec 22, 2023Pumping Problem; Pumping Problem

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A S5 MAST ROLLER PUMP GAVE A MOTOR CONTROL FAILURE ERROR MESSAGE DURING PRIMING. IT CANNOT BE EXCLUDED THAT THE PUMP STOPPED. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18381747 ↗
  • MalfunctionDec 19, 2023Pumping Stopped; Pumping Stopped

    SEE INITIAL REPORT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18353765 ↗
  • InjurySep 14, 2023Pumping Problem; Pumping Problem

    LIVANOVA DEUTSCHLAND HAS RECEIVED A REPORT THAT THE MAIN ARTERIAL PUMP FAILED WHILE WEANING OFF BYPASS. THE PATIENT IS STILL ALIVE AND SUFFER BRAIN INJURY. THE S5 IS SEIZED.

    Patient problems: Brain Injury

    MAUDE report 17744545 ↗
  • MalfunctionSep 14, 2023Pumping Stopped; Pumping Stopped

    LIVANOVA DEUTSCHLAND HAS RECEIVED A REPORT THAT THE SINGLE ROLLER PUMP 150 DISPLAYED INTERMITTENTLY ERROR "PUMP 1 MOTOR CONTROLLER ERROR" AND "PUMP 1 MOTOR MONITORING/CONTROLLING ERROR" OCCURRED RESPECTIVELY AT 17:16 ON (B)(6) AND AT 18:51 ON (B)(6). THERE IS NO REPORT OF ANY PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17744189 ↗
  • MalfunctionMar 3, 2023Pumping Stopped; Pumping Stopped

    SEE INITIAL REPORT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16477811 ↗
  • MalfunctionFeb 22, 2023Pumping Stopped; Pumping Stopped

    SEE INTIAL REPORT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16415778 ↗
  • MalfunctionFeb 10, 2023Pumping Stopped; Pumping Stopped

    SEE INTIAL REPORT

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16349693 ↗
  • MalfunctionJun 24, 2022Decreased Pump Speed; Decreased Pump Speed

    LIVANOVA RECEIVED REPORT THAT DASHES WERE DISPLAYED IN THE RPM MENU WITH/WITHOUT ROTATING THE SPEED KNOB OF A S5 MAST ROLLER PUMP. REPORTEDLY, THE PUMP WAS NOT SPINNING WHEN ROTATING THE SET KNOB. THE ISSUE OCCURRED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14798694 ↗
  • MalfunctionJun 8, 2022Pumping Stopped; Pumping Stopped

    LIVANOVA RECEIVED REPORT OF A MOTOR CONTROL FAILURE ERROR MESSAGE A PUMP USED ON A S5 SYSTEM DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14632145 ↗
  • MalfunctionMay 7, 2022Pumping Stopped; Pumping Stopped

    LIVANOVA (B)(4) RECEIVED A REPORT THAT A MOTOR CONTROL FAILURE ERROR MESSAGE WAS DISPLAYED ON A S5 MAST ROLLER PUMP WHICH STOPPED AT THE BEGINNING OF A PROCEDURE. REPORTEDLY, THE USER DECIDED TO HAND-CRANK THE PUMP FOR A WHILE AND THEN TURNED OFF AND BACK ON THE PUMP CONTROL PANEL. THE PUMP THEN CONTINUED TO FUNCTION NORMALLY. IT WAS COMMUNICATED THAT THE ERROR DID NOT RECUR AND THAT THE DEVICE IS WORKING PROPERLY SINCE THEN. THERE WAS NO REPORT OF PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14316856 ↗
  • MalfunctionFeb 7, 2022Pumping Stopped; Pumping Stopped

    LIVANOVA (B)(4) RECEIVED A REPORT THAT A S5 MAST ROLLER PUMP STOPPED DURING A PROCEDURE. THE USER HAND-CRANKED THE PUMP AND AFTER SEVERAL ATTEMPTS THE PUMP COULD BE STARTED AGAIN. THERE WAS NO REPORT OF PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13468734 ↗
  • MalfunctionMar 22, 2019Pumping Stopped; Pumping Stopped

    LIVANOVA (B)(4) RECEIVED A REPORT THAT A S5 MAST ROLLER PUMP STOPPED, FOLLOWING A LEVEL ALARM, AND IT DID NOT AUTOMATICALLY RESTART AFTER THE LEVEL FUNCTION DEACTIVATION. THE EVENT OCCURRED DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8443204 ↗
  • MalfunctionNov 16, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    LIVANOVA (B)(4) RECEIVED A REPORT THAT A S5 MAST ROLLER PUMP DISPLAYED AN ERROR MESSAGE DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8077203 ↗
  • MalfunctionAug 1, 2017Display or Visual Feedback Problem; Display or Visual Feedback Problem

    LIVANOVA (B)(4) RECEIVED A REPORT THAT THE S5 MAST ROLLER PUMP DID NOT PROPERLY READ THE FLOW DURING SETUP. THE DISPLAY SHOWED DASHES INSTEAD OF NUMBERS. THE CUSTOMER TRIED UNPLUGGING THE PUMP CONNECTOR FROM THE PANEL AND PLUGGING IT BACK IN, BUT THE ISSUE PERSISTED. SWAPPED OUT THE PUMP AND WAS ABLE TO PROCEED WITH THE SURGERY. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Patient Involvement

    MAUDE report 6757241 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.