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S5 Mast Roller Pump MRP 85Recalls & reported problems

LivaNova Deutschland GmbH · Class 2

All models of S5 Mast Roller Pump (4)

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

Adverse event reports
12
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04033817900481), received between Oct 11, 2019 and Aug 25, 2026 — classified as 12 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. 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: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 1 reportsMay 2024: 2 reportsJun 2024: 0 reportsJul 2024: 1 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 1 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 1 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 1 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 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: 1 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Pumping Stopped9
  • Pumping Problem2
  • Insufficient Device Problem Information1

Patient problems

  • No Clinical Signs, Symptoms or Conditions11
  • No Patient Involvement1

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 25, 2026Pumping Stopped

    LivaNova Deutschland received a report of an S5 Mast Roller Pump 85 for which a motor controller error occurred (432, "Fault in motor controller"). There was no patient injury.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50428663 ↗
  • MalfunctionJul 1, 2025Pumping Problem; Pumping Problem

    SEE INITIAL REPORT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22372431 ↗
  • MalfunctionMar 14, 2025Pumping Stopped; Pumping Stopped

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT, DURING PRIMING, CARDIOPLEGIA S5 MAST ROLLER PUMP STOPPED RUNNING. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21604246 ↗
  • MalfunctionOct 16, 2024Pumping Stopped; Pumping Stopped

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT AN S5 PUMP GAVE A MOTOR CONTROLLER ERROR MESSAGE DURING BYPASS. CUSTOMER WAS NOT ABLE TO TURN THE PUMP VIA THE DIAL, NO REVOLUTIONS POSSIBLE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20459259 ↗
  • MalfunctionJul 9, 2024Pumping Stopped; Pumping Stopped

    SEE INITIAL REPORT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19699276 ↗
  • MalfunctionMay 30, 2024Pumping Stopped; Pumping Stopped

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT, BEFORE STARTING CARDIOPULMONARY BYPASS, THE MAST ROLLER PUMP 85 LOST POWER, THEN RECOVERED NATURALLY, AND THEN AGAIN THE POWER WENT DOWN. BY REPLACING THE TUBING FROM THE DEFECTIVE PUMP TO ANOTHER PUMP, MEDICAL TEAM WAS ABLE TO START CARDIOPULMONARY BYPASS WITHOUT ANY PROBLEMS AND WITHOUT ANY IMPACT ON THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19423623 ↗
  • MalfunctionMay 28, 2024Pumping Stopped; Pumping Stopped

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

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19403891 ↗
  • MalfunctionApr 10, 2024Pumping Stopped; Pumping Stopped

    SEE INITIAL REPORT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19077499 ↗
  • MalfunctionNov 30, 2022Pumping Stopped; Pumping Stopped

    LIVANOVA RECEIVED REPORT OF A MOTOR CONTROL FAILURE ERROR MESSAGE ON A S5 MAST ROLLER PUMP WHEN USED FOR THE FIRST TIME DURING MAINTENANCE. THE PUMP WAS REPLACED WITH ANOTHER. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15884639 ↗
  • MalfunctionAug 2, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT OF A S5 MAST ROLLER PUMP DEFECT. NO ADDITIONAL INFORMATION WAS PROVIDED AND THE CASE HAS BEEN CONSERVATIVELY EVALUATED AS REPORTABLE. THERE WAS NO REPORT OF PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15147028 ↗
  • MalfunctionJul 14, 2022Pumping Stopped; Pumping Stopped

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A MAST ROLLER PUMP GAVE A MOTOR CONTROL FAILURE ERROR MESSAGE DURING PRIMING AND THE PUMP COULD NO LONGER BE STARTED. AFTERWARDS THE PUMP WORKED AND THE ERROR DID NOT RECUR. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15013553 ↗
  • MalfunctionOct 11, 2019Pumping Problem; Pumping Problem

    LIVANOVA (B)(4) RECEIVED A REPORT THAT RIGHT AFTER THE POWER OF THE CONTROL PANEL OF A S5 MAST ROLLER PUMP WAS TURNED ON, THE UNIT DID NOT OPERATE AND AN ERROR MESSAGE WAS DISPLAYED. THIS ISSUE WAS IDENTIFIED BY A LIVANOVA FIELD SERVICE REPRESENTATIVE DURING MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Patient Involvement

    MAUDE report 9178236 ↗

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Sources and updates

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