Electronic Gas BlenderRecalls & reported problems across all models
LivaNova Deutschland GmbH · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 106
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 3 models of Electronic Gas Blender by LivaNova Deutschland GmbH in the FDA's device registry (GUDID). Together they are named in 106 adverse event reports in the FDA's MAUDE database, received between Aug 1, 2016 and Sep 28, 2026 — classified as 105 malfunctions.
The most frequently reported specific device problem is “Gas Output Problem” (67 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 Electronic Gas Blender problems
Device problems
- Gas Output Problem67
- Device Displays Incorrect Message6
- Incorrect, Inadequate or Imprecise Result or Readings6
- Appropriate Device Problem Term/Code Not Available4
- Device Sensing Problem3
- Improper Flow or Infusion3
- Inaccurate Flow Rate3
- Device Operational Issue2
Patient problems
- No Clinical Signs, Symptoms or Conditions84
- No Patient Involvement13
- No Consequences Or Impact To Patient8
- Low Oxygen Saturation1
Electronic Gas Blender models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Electronic Gas Blender 10 l/minGas control unit, cardiopulmonary bypass98 reports
- Electronic Gas Blender 5 l/minGas control unit, cardiopulmonary bypass5 reports
- Electronic Gas Blender 2 l/minGas control unit, cardiopulmonary bypass3 reports
Recent Electronic Gas Blender adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Gas Output Problem
LivaNova Deutschland received a report of an Electronic Gas Blender (EGB) for which an error message was displayed and could not operate properly. The event occurred during priming.There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50912093 ↗MalfunctionSep 28, 2026Power Problem
LivaNova Deutschland received a report of an Electronic Gas Blender (EGB) which suddenly stopped working during priming and could not operate. Cold start and unplugging/re-plugging of unit's cables did not resolve the issue. Consequently, device was replaced with a new one.There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50911823 ↗MalfunctionSep 28, 2026Gas Output Problem
LivaNova Deutschland received a report of an Electronic Gas Blender (EGB) for which an error message was displayed and device could not operate properly. The event occurred during procedure.There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50911736 ↗MalfunctionSep 2, 2026Gas Output Problem
See initial report.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50565110 ↗MalfunctionApr 30, 2026Gas Output Problem
LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT THE ELECTRONIC GAS BLENDER (EGB) ACCURACY WAS OUTSIDE THE MEASUREMENT RANGE. THE EVENT WAS DETECTED DURING MAINTENANCE INSPECTION. THERE WAS NO PATIENT OR USER IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25045504 ↗MalfunctionMar 26, 2026Gas Output Problem
LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT THE ELECTRONIC GAS BLENDER (EGB) SHOWED FLOW OF 0,3 L/MIN DESPITE THE SET VALUE OF 0 L/MIN. AFTER RESTARTING IT, THE EGB WORKED AS EXPECTED. REPORTEDLY, THE ISSUE OCCURRED MULTIPLE TIMES, BUT IT IS NOT ALWAYS REPRODUCIBLE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24700309 ↗MalfunctionMar 10, 2026Incorrect, Inadequate or Imprecise Result or Readings
LIVANOVA DEUTSCHLAND HAS RECEIVED A REPORT CONCERNING AN ELECTRONIC GAS BLENDER (EGB) DELIVERING A FLOW RATE THAT DIFFERED FROM THE VALUE SHOWN ON THE DEVICE DISPLAY. THE CUSTOMER INDICATED THAT NO ERROR CODES WERE GENERATED; ONLY THE DELIVERED FLOW DID NOT CORRESPOND TO THE DISPLAYED FLOW RATE. THE ISSUE WAS REPORTEDLY OBSERVED DURING A PROCEDURE. NO PATIENT IMPACT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24555871 ↗MalfunctionDec 19, 2025Gas Output Problem; Gas Output Problem
LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT THE S5 HLM ELECTRONIC GAS BLENDER SHOWED ERROR 19 DURING PRIMING. THERE IS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23848141 ↗MalfunctionDec 17, 2025Gas Output Problem; Gas Output Problem
LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT THE ELECTRONIC GAS BLENDER WAS NOT WORKING PROPERLY AND DISPLAYED ERROR CODE 1000. THE ISSUE OCCURRED DURING INSTALLATION. THERE IS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23826293 ↗MalfunctionDec 12, 2025Gas Output Problem; Gas Output Problem
LIVANOVA DEUTSCHLAND RECEIVED A REPORT ABOUT AN ERROR CONCERNING THE S5 HLM GAS BLENDER. THE ISSUE OCCURRED DURING PROCEDURE. THERE IS NO REPORT OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23787383 ↗MalfunctionNov 21, 2025Gas Output Problem; Gas Output Problem
SEE INITIAL REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23617827 ↗MalfunctionNov 20, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
SEE INITIAL REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23605562 ↗MalfunctionNov 13, 2025Gas Output Problem; Gas Output Problem
LIVANOVA DEUTSCHLAND RECEIVED A REPORT OF AN ELECTRONIC GAS BLENDER WHICH DISPLAYED ERROR MESSAGE ONTO DISPLAY (E19, "CALIBRATION FAULT"). THE EVENT OCCURRED DURING REGULAR MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23543976 ↗MalfunctionNov 7, 2025Gas Output Problem; Gas Output Problem
LIVANOVA DEUTSCHLAND RECEIVED REPORT OF AN ELECTRONIC GAS BLENDER (EGB) THAT WAS NOT WORKING PROPERLY. THE ISSUE OCCURRED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23498448 ↗MalfunctionOct 31, 2025Gas Output Problem; Gas Output Problem
SEE INITIAL REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23433960 ↗
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
- Electrical Remote-Controlled Tubing Clamp3 models · 85 reports
- S5 Double Roller Pump 852 models · 59 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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