EkoSonic® 6779-005Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00858593006165), received between Feb 11, 2020 and Sep 5, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 5, 2024Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  IT WAS REPORTED THAT THE DRUG LUER WAS CRACKED AND LEAKING. THIS 106X30CM EKOSONIC ENDOVASCULAR DEVICE WAS SELECTED FOR USE FOR A DEEP VEIN THROMBOSIS POPLITEAL PROCEDURE. THE CATHETER WAS PLACED, AND THE PATIENT WAS BROUGHT TO THE INTENSIVE CARE UNIT FOR TREATMENT. AT THAT TIME, LYTIC THERAPY COULD NOT BE STARTED DUE TO A CRACKED AND LEAKING DRUG LUER. AN ATTEMPT WAS MADE TO REPAIR THE DRUG LUER AND RUN THE CATHETER AS A STANDARD INFUSION CATHETER; HOWEVER, DRUG CONTINUED TO LEAK FROM THE LUER. NO PATIENT COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20146967 ↗
• MalfunctionMar 26, 2024Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THIS DEVICE WAS LEAKING AND THE PATIENT DEVELOPED PNEUMOTHORAX. THIS 106X30CM EKOSONIC ENDOVASCULAR DEVICE WAS SELECTED FOR USE IN A PULMONARY EMBOLISM PROCEDURE. THE CATHETER WAS PLACED, AND THE PATIENT WAS TAKEN TO THE INTENSIVE CARE UNIT FOR TREATMENT OVERNIGHT. LEAKING FROM THE DRUG PORT WAS LATER OBSERVED. PER PHYSICIANS ORDERS, THE COOLANT AND DRUG WERE INFUSED TOGETHER THROUGH THE COOLANT PORT. ADDITIONALLY, IT WAS NOTED THAT THE PATIENT DEVELOPED PNEUMOTHORAX. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE.

  Patient problems: Pneumothorax

  MAUDE report 18979077 ↗
• MalfunctionNov 6, 2023Device Alarm System; Temperature Problem; Device Alarm System; Temperature Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 17OCT2023. AN EKOSONIC ENDOVASCULAR DEVICE, 106X30CM WAS SELECTED FOR USE IN A BILATERAL EKOS PROCEDURE. AFTER APPROXIMATELY 90 MINUTES OF EKOS THERAPY, THERE WERE MULTIPLE ERROR MESSAGES OBSERVED ON THE CONTROL UNIT. TROUBLESHOOTING WAS UNABLE TO RESOLVE THE ISSUE. THE EKOS DEVICE WAS RAN AS A STANDARD INFUSION CATHETER WITHOUT THE USE OF ULTRASOUND TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED PATIENT COMPLICATIONS. HOWEVER, DEVICE ANALYSIS REVEALED THE ULTRASONIC CORE (USC) WAS FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18075173 ↗
• MalfunctionFeb 11, 2020Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem

  ON (B)(6) 2020, 17 HOURS INTO THERAPY, ICU NURSE CALLED WITH AN ALL MSD GROUPS DISABLED ALARM. THE CATHETER WAS USED TO TREAT A PERIPHERAL ARTERIAL OCCLUSION (PAO). SHE MENTIONED THAT THE BLACK CABLE MAY HAVE BEEN KINKED WHEN THE CONTROL UNIT (CU) ALARMED, BUT THAT IT WAS THEN STRAIGHTENED OUT. TROUBLESHOOTING PERFORMED DID NOT CLEAR THE ALARM. THE NURSE WAS INSTRUCTED TO NOTIFY THE DOCTOR THAT THE CATHETER WOULD NOW RUN AS A BASIC INFUSION CATHETER. THE PATIENT WAS "DOING GREAT". ON 30 JANUARY 2020, INVESTIGATION OF THE RETURNED DEVICE REVEALED THAT THE MICROSONIC DEVICE (MSD) SHORTED DUE TO FLUID INGRESS INTO THE HUB AFTER 17 HOURS OF THERAPY. THIS WAS NOT REPORTED BY THE CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9696617 ↗