S5 Double Roller Pump 85Recalls & reported problems across all models
LivaNova Deutschland GmbH · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 59
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 2 models of S5 Double Roller Pump 85 by LivaNova Deutschland GmbH in the FDA's device registry (GUDID). Together they are named in 59 adverse event reports in the FDA's MAUDE database, received between Jun 8, 2016 and Mar 17, 2026 — classified as 57 malfunctions.
The most frequently reported specific device problem is “Pumping Stopped” (30 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported S5 Double Roller Pump 85 problems
Device problems
- Pumping Stopped30
- Device Displays Incorrect Message10
- Pumping Problem7
- Appropriate Device Problem Term/Code Not Available3
- Device Alarm System2
- Failure to Auto Stop2
- Image Display Error/Artifact2
- No Display/Image2
Patient problems
- No Clinical Signs, Symptoms or Conditions35
- No Patient Involvement18
- No Consequences Or Impact To Patient6
S5 Double Roller Pump 85 models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- S5 Double Roller Pump 85 DRP 85CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS54 reports
- S5 Double Roller Pump 85 DRP 85CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS5 reports
Recent S5 Double Roller Pump 85 adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 17, 2026Pumping Stopped
LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT, DURING PROCEDURE, A S5 DOUBLE ROLLER PUMP HAD AN INTERNAL ALARM. THE MESSAGE DISPLAY READ "INTERNAL TEMPERATURE IS TOO HIGH". REPORTEDLY, PUMP WAS NOT ROTATING SMOOTHLY BUT JERKY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24616385 ↗MalfunctionMar 10, 2026Application Program Problem
LIVANOVA DEUTSCHLAND HAS RECEIVED A REPORT CONCERNING AN ESSENZ HEART-LUNG MACHINE (HLM) COCKPIT THAT BRIEFLY BLACKED OUT AFTER THE PERFUSIONIST REVERSED THE PUMP DIRECTION DURING A PROCEDURE. NO PATIENT INJURY HAS BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24556530 ↗MalfunctionFeb 27, 2026Pumping Problem
SEE INITIAL REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24471746 ↗MalfunctionSep 3, 2025Failure to Auto Stop; Failure to Auto Stop
SEE INITIAL REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22950145 ↗MalfunctionMay 7, 2025Pumping Stopped; Pumping Stopped
LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT, DURING A PROCEDURE, THE S5 DOUBLE ROLLER PUMP 85 FAILED AND SHUT OFF 10 SECOND AFTER BEING TURNED ON (NO FLOW). THERE IS NO REPORT OF ANY PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21976561 ↗MalfunctionNov 29, 2024Pumping Problem; Pumping Problem
SEE INITIAL REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20809263 ↗MalfunctionNov 13, 2024Pumping Stopped; Pumping Stopped
SEE INITIAL REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20672345 ↗MalfunctionOct 9, 2024Pumping Stopped; Pumping Stopped
LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A S5 DOUBLE ROLLER PUMP 85 HEAD MALFUNCTIONED WHEN IT WAS IN SERVICE. IT WAS THE BLOOD PUMP ON THE CARDIOPLEGIA DOUBLE HEADER. THE AFFECTED PUMP HAS BEEN REPLACED WITH A SPARE ONE. NO ADDITIONAL INFORMATION IS AVAILABLE SO FAR. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20407313 ↗MalfunctionOct 9, 2024Pumping Stopped; Pumping Stopped
LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A S5 DOUBLE ROLLER PUMP 85 HEAD MALFUNCTIONED WHEN IT WAS IN SERVICE. IT WAS THE BLOOD PUMP ON THE CARDIOPLEGIA DOUBLE HEADER. THE AFFECTED PUMP HAS BEEN REPLACED WITH A SPARE ONE. NO ADDITIONAL INFORMATION IS AVAILABLE SO FAR. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20407264 ↗MalfunctionAug 28, 2024Pumping Stopped; Pumping Stopped
LIVANOVA RECEIVED A REPORT ABOUT CONSOLE ALARMS WITH "FAULT IN MOTOR CONTROLLER (431) PUMP 2A (BLOOD) , FAULT IN MOTOR CONTROLLER (433) PUMP 2A (BLOOD) AND FAULT IN MOTOR CONTROLLER (442) PUMP 2A (BLOOD)" WHEN TURNED ON. THE FIELD SERVICE ENGINEER HAS DONE THE SWAPPING PROCESS WITH OTHER SPARE PARTS TO DETERMINE WHICH SPARE PARTS ARE DAMAGED. IT WAS CONCLUDED THAT THE DAMAGE WAS ON THE POWER AMPLIFIER MOTOR BOARD AND THE ROLLER PUMP 85 PUMP HEAD ROTOR IN PUMP 2A.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20085551 ↗MalfunctionJul 8, 2024Pumping Stopped; Pumping Stopped
LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A S5 DOUBLE HEAD PUMP GAVE A FAULT IN MOTOR CONTROLLER ERROR MESSAGE (CODE 442) DURING PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19687681 ↗MalfunctionJul 5, 2024Pumping Problem; Pumping Problem
LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A S5 DOUBLE HEAD PUMP GAVE AN INTERMITTENT ERROR (ROTATION DETECTOR ERROR VALUE) DURING PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19678251 ↗MalfunctionMar 6, 2024Pumping Problem; Pumping Problem
SEE INITIAL REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18844770 ↗MalfunctionJan 12, 2024Pumping Stopped; Pumping Stopped
SEE INTIAL REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18500849 ↗MalfunctionOct 31, 2023Device Alarm System; Device Alarm System
LIVANOVA DEUTSCHLAND HAS RECEIVED A REPORT THAT THE ROLLER PUMP 85 TWIN PUMPS WENT IN A RUNAWAY STATE. PUMPS DISPLAYED ERROR CODE 1A AND ERROR INDICATING THAT PUMP SPINNING IN THE OPPOSITE DIRECTION. THE ISSUES OCCURRED DURING A PROCEDURE. THERE IS NO REPORT OF ANY PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18038950 ↗
Other LivaNova Deutschland GmbH products
- Heater-Cooler System2 models · 311 reports · 1 recall
- ESSENZ8 models · 185 reports · 1 recall
- CP54 models · 96 reports · 1 recall
- S5 Console7 models · 141 reports
- S5 Roller Pump 1502 models · 135 reports
- Electronic Gas Blender3 models · 106 reports
- Electrical Remote-Controlled Tubing Clamp3 models · 85 reports
- S5 Mast Roller Pump4 models · 47 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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