EkoSonic® 6779-004Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00858593006158), received between Mar 29, 2023 and Oct 24, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 24, 2024Leak/Splash; Obstruction of Flow; Leak/Splash; Obstruction of Flow

  IT WAS REPORTED THAT THERE WAS A DRUG LEAK AND OCCLUSION. AN EKOSONIC ENDOVASCULAR DEVICE, 106X24CM WAS SELECTED FOR USE IN A UNILATERAL THROMBOLYSIS PROCEDURE. AFTER SEVEN HOURS OF EKOS THERAPY, WHILE IN THE ICU, IT WAS OBSERVED THAT THERE WAS A WET SPOT IN THE PATIENT'S BED AND SOME BLOOD BACKING UP IN THE DRUG LUER. THE NURSE ATTEMPTED TO FLUSH THE CATHETER AND OBSERVED THAT FLUID SQUIRTED SIDEWAYS OUT OF THE DRUG INFUSION TUBING, BELOW THE HUB WHERE THE STOPCOCK WAS CONNECTED. THERE WAS A PINHOLE LEAK IN THE HUB OF THE DRUG INFUSION TUBING. THE LINE INTO THE PATIENT WAS COMPLETELY OCCLUDED. TROUBLESHOOTING WAS UNABLE TO RESOLVE THE ISSUE. THE TPA WAS RUN AT A SLOWER RATE TO BYPASS THE ISSUE AND THERAPY WAS COMPLETED IN THE MORNING. THROMBUS WAS RESOLVED. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20523485 ↗
• InjuryMar 29, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE DISTAL MARKER BAND DETACHED FROM THE CATHETER, AND REMAINED IN THE PATIENT. AN EKOSONIC ENDOVASCULAR DEVICE, 106X24CM WAS SELECTED FOR USE IN THE ILIAC. THE CATHETER WAS ADVANCED TO THE TARGET LESION, BUT WAS UNABLE TO PASS DUE TO SEVERE STENOSIS. THE CATHETER WAS ATTEMPTED TO BE WITHDRAWN, AT WHICH POINT THE DISTAL MARKER BAND DETACHED. THE PHYSICIAN ELECTED TO LEAVE THE DEVICE FRAGMENT IN THE PATIENT, AS THERE WAS A LIMITED RISK OF THE MARKER BAND MIGRATING FROM THE SEVERE STENOSIS. THE PROCEDURE WAS ABORTED AT THIS TIME, AND THE PATIENT WAS NOT TREATED. THERE WERE NO FURTHER CONSEQUENCES REPORTED FOR THE PATIENT. THE PATIENT WAS REPORTED TO BE DOING FINE.

  Patient problems: Foreign Body In Patient

  MAUDE report 16639372 ↗