EVO OccluderRecalls & reported problems
LivaNova Deutschland GmbH · Class 2
All models of EVO (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This LivaNova EVO Occluder is a vascular clamp used to close off veins during surgery. The 29 reports mostly describe the clamp being hard to open or close, showing error messages on its control panel, or not closing properly during procedures, sometimes forcing the surgical team to switch to hand tools. No deaths and no injuries were reported. There are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 31
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 04033817900504), received between Jan 16, 2018 and Sep 9, 2026 — classified as 31 malfunctions.
The most frequently reported specific device problem is “Difficult to Open or Close” (26 reports).
1 other recall cover devices cleared under the same FDA submission (K082344); they may or may not involve this specific model.
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
- Difficult to Open or Close26
- Appropriate Device Problem Term/Code Not Available2
- Device Operational Issue2
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions27
- No Consequences Or Impact To Patient4
Recent adverse event reports
The 25 most recent of 31 reports, 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 ↗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 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 ↗MalfunctionApr 16, 2024Difficult to Open or Close; Difficult to Open or Close
LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT, AFTER PRIMING WAS COMPLETED, A S5 EVO TUBING CLAMP DISPLAYED FAULTY RC_ANGLE_ERROR (E1538) AND IT CAN NO LONGER BE OPERATED. AFTER THAT, THE DEVICE WAS TURNED IT ON AND OFF SEVERAL TIMES AND IT IMPROVED. THERE IS NO REPORT OF ANY PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19116023 ↗MalfunctionMar 13, 2024Difficult to Open or Close; Difficult to Open or Close
SEE INITIAL REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18892598 ↗MalfunctionMar 13, 2024Difficult to Open or Close; Difficult to Open or Close
LIVANOVA RECEIVED REPORT THAT A ELECTRICAL VENOUS OCCLUDER (EVO) GAVE AN ERROR (E1538) CODE ASSOCIATED TO THE CLAMP ENCODER PROBABLY DURING INSTALLATION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18892592 ↗MalfunctionMar 13, 2024Difficult to Open or Close; Difficult to Open or Close
SEE INITIAL REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18892577 ↗MalfunctionMar 7, 2024Difficult to Open or Close; Difficult to Open or Close
LIVANOVA RECEIVED REPORT THAT A ELECTRICAL VENOUS OCCLUDER (EVO) GAVE AN ERROR RC_POSITION_NOT_CLOSE (E1545) AND WAS MALFUNCTIONING DURING PRE-USE INSPECTION. EVO HAS BEEN POWERED OFF AND ON AND IT DID NOT CLEAR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18854440 ↗MalfunctionJan 15, 2024Difficult to Open or Close; Difficult to Open or Close
LIVANOVA DEUTSCHLAND HAS RECEIVED A REPORT THAT, DURING A PROCEDURE, THE VENOUS OCCLUDER WAS NOT RESPONSIVE. THERE IS NO REPORT OF ANY PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18510601 ↗MalfunctionJul 20, 2023Difficult to Open or Close; Difficult to Open or Close
LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT AN ELECTRICAL VENOUS OCCLUDER (EVO) GAVE AN ERROR MESSAGE RELATED TO OVER-CURRENT AT MOTOR CONTROLLER (LOW SIDE) DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17359206 ↗MalfunctionFeb 16, 2023Difficult to Open or Close; Difficult to Open or Close
LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT AN ELECTRICAL VENOUS OCCLUDER (EVO) CLAMP GAVE AN ERROR MESSAGE ASSOCIATED TO A FAULTY ENCODER AT ITS THE FIRST USE BY THE CUSTOMER DURING PROCEDURE. IT WAS REPLACED WITH A LOANER UNIT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16384948 ↗MalfunctionJan 27, 2023Difficult to Open or Close; Difficult to Open or Close
SEE INITIAL REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16252159 ↗MalfunctionOct 7, 2022Difficult to Open or Close; Difficult to Open or Close
LIVANOVA RECEIVED REPORT OF ELECTRICAL VENOUS OCCLUDER (EVO) NOT WORKING DURING PROCEDURE. NO ADDITIONAL DETAIL WAS PROVIDED AND A REPORTABLE MALFUNCTION CANNOT BE EXCLUDED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15560527 ↗MalfunctionSep 15, 2022Difficult to Open or Close; Difficult to Open or Close
LIVANOVA RECEIVED REPORT THAT A ELECTRICAL VENOUS OCCLUDER (EVO) GAVE AN ALARM DURING PRIMING. THE CUSTOMER DID NOT REMEMBER THE EXACT ERROR CODE AND A REPORTABLE MALFUNCTION CANNOT BE EXCLUDED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15427515 ↗MalfunctionMay 12, 2022Difficult to Open or Close; Difficult to Open or Close
LIVANOVA RECEIVED REPORT THAT ELECTRICAL VENOUS OCCLUDER (EVO) GAVE SOME PROBLEMS SPORADICALLY. REPORTEDLY, THE CLAMP DISPLAYED ERRORS DURING CALIBRATION AND ALSO DURING USE AND RECENTLY GAVE AN ERROR CODE ASSOCIATED TO THE CLAMP ENCODER. THERE WAS NO REPORT OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14373719 ↗MalfunctionMay 5, 2022Difficult to Open or Close; Difficult to Open or Close
LIVANOVA RECEIVED REPORT OF A ELECTRICAL VENOUS OCCLUDER (EVO) GIVING AN ERROR MESSAGE DURING A PROCEDURE AND DASHES WERE SHOWN ON THE PERCENTAGE (%) OF CLAMP OPENING DISPLAY OF THE CONTROLLER. REPORTEDLY, THE DISPLAY DISAPPEARED AND THE OPERATION RETURNED TO NORMAL WHEN THE MUTE ON THE SYSTEM PANEL WAS PRESSED. THERE WAS NO REPORT OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14288691 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K082344. One submission often covers many models, so check the product and lot details in each record.
- Z-2075-2010 · Jun 18, 2010 · TerminatedElectrical Venous Occluder, Catalog 12-80-00, for use with Sorin HLM C5 and HLM S5.
Other CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS devices
- DLP™ 77010Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 recall154 reports
- EOPA™ 77422Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls19 reports
- DLP™ 77008Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls9 reports
- NA HY11W65R1Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls8 reports
- DLP® 12113Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls6 reports
- DLP® Aortic Root Cannula with Flow-Guard™ 11012Medtronic, Inc. · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS2 recalls5 reports
- EOPA™ 77622Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls4 reports
- NA HY11R00R6Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls3 reports
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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