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
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
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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