EkoSonic® 6779-001Recalls & reported problems

Boston Scientific Corporation · The EkoSonic® Endovascular Device consists of a single use Infusion Catheter and an Ultrasonic Core. The device delivers physician-specified fluids and ultrasound to the intravascular treatment site. It comes in different working lengths and treatment zones. · Class 2

All models of EkoSonic (11)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00858593006028), received between Jan 16, 2020 and Jun 11, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Audible Prompt/Feedback Problem” (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 18, 2026.

Most reported problems

Device problems

Audible Prompt/Feedback Problem1
Difficult to Flush1
Leak/Splash1
Obstruction of Flow1

Patient problems

No Clinical Signs, Symptoms or Conditions1
No Consequences Or Impact To Patient1

Recent adverse event reports

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

MalfunctionJun 11, 2021Difficult to Flush; Leak/Splash; Obstruction of Flow; Difficult to Flush; Leak/Splash; Obstruction of Flow
IT WAS REPORTED THAT A DRUG OCCLUSION AND LEAK OCCURRED. AN EKOSONIC CATHETER WAS SELECTED FOR USE DURING A LOWER EXTREMITY ARTERIAL THROMBOLYSIS PROCEDURE. APPROXIMATELY 7 HOURS INTO THERAPY, BLOOD WAS NOTED IN THE DRUG PORT. THE LYTIC BAG WAS CHANGED AN HOUR BEFORE. TROUBLESHOOTING WAS PERFORMED AND A LEAK FROM THE THREE WAY STOPCOCK WAS NOTED. THE NURSE ATTEMPTED TO FLUSH WITH A 3 CC SYRINGE, BUT WAS UNSUCCESSFUL. BACK PRESSURE WAS RELEASED AND ANOTHER FLUSH WAS ATTEMPTED FOR NO RESOLUTION. AT THIS TIME, THE PHYSICIAN DECIDED TO SEND THE PATIENT BACK FOR RECHECK. NO FURTHER INFORMATION IS KNOWN AT THIS TIME. THIS REPORT WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11984357 ↗
MalfunctionJan 16, 2020Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem
ON (B)(6) 2019, EKOS DISTRIBUTOR REPORTED THAT AN ERROR OCCURRED WITHIN 24 HOURS OF TREATMENT. EKOS CATHETER WAS USED FOR A PULMONARY EMBOLISM TREATMENT. THE ALARM COULD NOT BE RESOLVED AFTER CHANGING TO ANOTHER CONTROL UNIT. A REPLACEMENT EKOSONIC CATHETER WAS USED TO COMPLETE THE TREATMENT. THE PATIENT WAS REPORTED AS STABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9598275 ↗

Device details

UDI-DI	`00858593006028`
Brand	EkoSonic®
Model	6779-001
Catalog no.	500-55106
Company	Boston Scientific Corporation
Product code	KRA · Catheter, Continuous Flush
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	May 25, 2021

Device type (GMDN): Ultrasound thrombolysis system catheter, pulmonary

A flexible tube designed for the percutaneous intravascular administration of high-frequency, low-energy ultrasound and drugs [e.g., tissue plasminogen activator (tPA)] for the disruption of clotted blood (i.e., a thrombus or thromboembolus) in the pulmonary arterial system. It typically consists of a side-hole drug infusion catheter with a multi-element ultrasound core wire. The ultrasound is intended to prepare the clot by unwinding the fibrin strands, therefore enabling increased drug permeation through the clot to the vessel wall. It is a component of a system that includes a control unit to deliver the ultrasound. This is a single-use device.

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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
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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