EVO Control UnitRecalls & reported problems
LivaNova Deutschland GmbH · Class 2
All models of EVO (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04033817900801), received between Jul 12, 2023 and Sep 11, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Difficult to Open or Close” (5 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 Close5
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗MalfunctionAug 25, 2023Difficult to Open or Close; Difficult to Open or Close
SEE INTIAL REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17621985 ↗MalfunctionJul 12, 2023Difficult to Open or Close; Difficult to Open or Close
SEE INITIAL REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17304241 ↗
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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