EVORecalls & 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
- 36
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 2 models of EVO by LivaNova Deutschland GmbH in the FDA's device registry (GUDID). Together they are named in 36 adverse event reports in the FDA's MAUDE database, received between Jan 16, 2018 and Sep 9, 2026 — classified as 36 malfunctions.
The most frequently reported specific device problem is “Difficult to Open or Close” (31 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 EVO problems
Device problems
- Difficult to Open or Close31
- Appropriate Device Problem Term/Code Not Available2
- Device Operational Issue2
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions32
- No Consequences Or Impact To Patient4
EVO models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- EVO OccluderCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS31 reports
- EVO Control UnitCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS5 reports
Recent EVO adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2026Difficult to Open or Close
LivaNova Deutschland received a report of an Electronic Venous Occluder (EVO) which could not fully close when the device opening value was set to 0%. The event occurred during setup.There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50691724 ↗MalfunctionAug 10, 2026Unintended Movement
LivaNova Deutschland received a report that Electronic Venous Occluder (EVO) displayed an error code indicating that it was not working properly during procedure. Reportedly, error acknowledgement temporarily cleared after cleaning procedure and then it reappeared.There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50189946 ↗MalfunctionMar 31, 2026Difficult to Open or Close
LIVANOVA DEUTSCHLAND RECEIVED A REPORT OF AN ELECTRONIC VENOUS OCCLUDER CLAMP (EVO) SHOWING AN ERROR MESSAGE ON SYSTEM PANEL. THERE IS NO REPORT OF ANY PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24740370 ↗MalfunctionMar 19, 2026Difficult to Open or Close
LIVANOVA DEUTSCHLAND RECEIVED A REPORT REGARDING THE ERROR MESSAGE "OCCLUDER 1 IS EITHER DISCONNECTED OR MALFUNCTIONING", DURING SERVICE, OF AN EVO CLAMP OCCLUDER. THE ALARM STOPPED AFTER TURNING ON AND OFF THE DEVICE SEVERAL TIMES. THERE IS NO REPORT OF ANY PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24636401 ↗MalfunctionNov 27, 2025Difficult to Open or Close; Difficult to Open or Close
LIVANOVA DEUTSCHLAND RECEIVED A REPORT OF AN ELECTRONIC VENOUS OCCLUDER (EVO) WHICH DID NOT FUNCTION PROPERLY AND AN ERROR MESSAGE HAS BEEN DISPLAYED. THE EVENT OCCURRED DURING PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23666201 ↗MalfunctionNov 7, 2025Difficult to Open or Close; Difficult to Open or Close
LIVANOVA DEUTSCHLAND RECEIVED A REPORT OF AN ELECTRONIC VENOUS OCCLUDER (EVO) WHICH DID NOT FUNCTION PROPERLY. THE EVENT OCCURRED DURING PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23495440 ↗MalfunctionSep 11, 2025Difficult to Open or Close; Difficult to Open or Close
SEE INTIAL REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23024845 ↗MalfunctionFeb 6, 2025Difficult to Open or Close; Difficult to Open or Close
LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT THE KNOBS ON AN ELECTRONIC VENOUS OCCLUDER (EVO) CONTROL UNIT NO LONGER RESPONDED WHEN TURNED. THE ISSUE OCCURRED DURING PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21322654 ↗MalfunctionDec 12, 2024Difficult to Open or Close; Difficult to Open or Close
SEE INITIAL REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20913481 ↗MalfunctionNov 21, 2024Difficult to Open or Close; Difficult to Open or Close
LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT THE CONTROLLER KNOB OF AN ELECTRONIC VENOUS OCCLUDER (EVO), THAT ADJUSTS THE OPENING DEGREE, WAS STUCK. THE ISSUE OCCURRED AT SETUP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20746606 ↗MalfunctionNov 15, 2024Difficult to Open or Close; Difficult to Open or Close
LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT AN ELECTRONIC VENOUS OCCLUDER (EVO) GAVE AN ERROR MESSAGE DURING PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20693059 ↗MalfunctionOct 24, 2024Difficult to Open or Close; Difficult to Open or Close
LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT, DURING A PROCEDURE, THE OCCLUDER MALFUNCTION ALERT WAS ISSUED MULTIPLE TIMES, SO THE OPERATION WAS COMPLETED BY SWITCHING TO FORCEPS OPERATION. THERE IS NO REPORT OF ANY PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20523190 ↗MalfunctionOct 10, 2024Difficult to Open or Close; Difficult to Open or Close
LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT AN ELECTRONIC VENOUS OCCLUDER (EVO) DID NOT CLOSE CORRECTLY DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20417061 ↗MalfunctionAug 8, 2024Difficult to Open or Close; Difficult to Open or Close
LIVANOVA RECEIVED A REPORT THAT AN ALARM REFERRING TO A DEFECTIVE ELECTRICAL VENOUS OCCLUDER (EVO) WAS DISPLAYED. THE EVENT OCCURRED DURING THE SETUP OF THE DEVICE, BEFORE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19938401 ↗MalfunctionAug 7, 2024Difficult to Open or Close; Difficult to Open or Close
LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT AN ELECTRICAL VENOUS OCCLUDER (EVO) GAVE AN ERROR MESSAGE DURING PROCEDURE. NO ADDITION INFORMATION IS AVAILABLE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19928361 ↗
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 Double Roller Pump 852 models · 59 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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