EKOS™ EKOS Control Unit 4.0Recalls & reported problems
Boston Scientific Corporation · The EKOS™ Control Unit provides power to the Ultrasonic Core and monitors parameters during operation via the CIC. The Control Unit also provides the user interface for operator control. · Class 2
All models of EKOS + (4)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00858593006462), received between Aug 28, 2024 and Aug 28, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Output Problem” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Oct 13, 2022Open, Classified
Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU.
Z-0149-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Output Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 28, 2024Output Problem; Output Problem
IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. DURING A BILATERAL EKOS PROCEDURE, THE CONTROL UNIT 4.0 STARTED ALARMING WITH AN E311 ERROR ON BOTH CATHETERS. TROUBLESHOOTING WAS PERFORMED BUT WAS UNABLE TO RESOLVE THE ALARM. THE EKOS THERAPY WAS DISCONTINUED APPROXIMATELY THREE HOURS AFTER THE TREATMENT STARTED. THERE WERE NO REPORTED PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20089455 ↗
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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 · each recall links to the FDA recall notice
- 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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