EkoSonic® 6779-006Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00858593006172), received between Sep 14, 2017 and Aug 22, 2024 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Electrical Shorting” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A LEAK OCCURRED. A 106X40CM EKOSONIC ENDOVASCULAR DEVICE WAS SELECTED FOR USE IN A LEG CASE WITH AN ANTEGRADE APPROACH. WHILE ADMINISTERING THERAPY IN THE INTENSIVE CARE UNIT (ICU), THE NURSE CALLED THE EKOS HELPLINE FOR INFORMATION REGARDING TRANSPORTATION OF THE PATIENT WHILE ON EKOS TO THE COMPUTERIZED TOMOGRAPHY (CT) SCANNER. THE PATIENT HAD BECOME MORE CONFUSED OVER THE COURSE OF THE NURSE'S SHIFT, AND THE PHYSICIAN ORDERED A CT SCAN TO RULE OUT POTENTIAL ISSUES IN THE PATIENT'S BRAIN. LATER ON, THE EKOS HELPLINE WAS CALLED BACK, AND IT WAS REPORTED THAT THE EKOS CATHETER WAS AT 48 HOURS OF USAGE AND WAS NOW LEAKING AT THE BLUE PIECE THAT ATTACHES THE MANIFOLD TO THE CATHETER. THE CATHETER WAS PULLED PER THE PHYSICIAN'S ORDERS. THE CT SCAN CAME BACK NEGATIVE FOR ANY BLEED. THE PATIENT WAS RECOVERING WELL, AND PRESSURE WAS APPLIED TO THE STICK SITE POST REMOVAL OF THE CATHETER.

  Patient problems: Confusion/ Disorientation

  MAUDE report 20043486 ↗
• InjuryJul 3, 2024Break; Break

  IT WAS REPORTED THAT THE ULTRASONIC CORE BROKE OFF INSIDE THE PATIENT REQUIRING SURGICAL REMOVAL. ON (B)(6) 2024, THE PATIENT PRESENTED WITH THORACIC OUTLET SYNDROME AND UNDERWENT A CATHETER-DIRECTED THROMBOLYSIS PROCEDURE WITH A 40 CM X 106 CM EKOS CATHETER. THE CATHETER WAS PLACED IN THE LEFT SUBCLAVIAN VEIN. IT WAS NOTED THAT A 24 CM X 106 CM EKOS CATHETER AND A 40 CM X 106 CM EKOS CATHETER WERE USED OR ASSIGNED TO THIS PATIENT. FOLLOWING CATHETER PLACEMENT, THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) FOR THROMBOLYTIC INFUSION. THERE WERE NO REPORTED ISSUES ENCOUNTERED AT THE TIME OF THE PROCEDURE. FOLLOWING OVERNIGHT THROMBOLYSIS VIA THE EKOS CATHETER, THE PATIENT RETURNED TO THE CATHETERIZATION LABORATORY ON (B)(6) 2024 FOR A CATHETER CHECK. REPORTEDLY THIS WAS UNEVENTFUL, AND THE EKOS CATHETER WAS REMOVED OVER A WIRE. THE PATIENT UNDERWENT BALLOON ANGIOPLASTY OF THE LEFT SUBCLAVIAN VEIN. THE PATIENT WAS DISCHARGED, AND FIVE TO SIX DAYS LATER UNDERWENT LEFT FIRST RIB RESECTION AND RELEASE OF THE THORACIC OUTLET. ON (B)(6) 2024, THE PATIENT WAS ADMITTED TO A DIFFERENT FACILITY WITH CHEST PAIN. COMPUTED TOMOGRAPHY (CT) IMAGING REVEALED A FOREIGN BODY WITHIN THE INF

  Patient problems: Chest Pain; Pericardial Effusion

  MAUDE report 19667679 ↗
• MalfunctionMay 13, 2024Communication or Transmission Problem; Connection Problem; Adverse Event Without Identified Device or Use Problem; Output Problem; Communication or Transmission Problem; Connection Problem; Adverse Event Without Identified Device or Use Problem; Output Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 03MAY2024. THE RETURNED DEVICE EVALUATION REVEALED THAT THE DEVICE HAD A SEPARATED ULTRASONIC CORE, AND THE DRUG AND COOLANT LUERS WERE CRACKED AND LEAKING. THIS EKOSONIC ENDOVASCULAR DEVICE, 106X40CM WAS SELECTED FOR USE IN A UNILATERAL DEEP VEIN THROMBOSIS PROCEDURE. ALARMS E006, E302, AND E311 WERE OBSERVED DURING TREATMENT WHICH WERE UNABLE TO BE RESOLVED DESPITE TROUBLESHOOTING ATTEMPTS. THEREFORE, THE CATHETER WAS USED AS A STANDARD INFUSION CATHETER TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19305443 ↗
• InjuryMay 20, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE PATIENT WAS BROUGHT BACK TO THE CATHETERIZATION LAB FOR CATHETER REPLACEMENT. A 106X40CM EKOSONIC CATHETER WAS SELECTED FOR USE IN A 4 HOUR LEFT ARTERIAL UNILATERAL CASE. TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS GIVEN AT 25ML/HR AND COOLANT WAS AT 35ML/HR. DIFFICULTY PLACING THE CATHETER IN THE LEFT LEG OCCURRED. AN ALL GROUPS DISABLED ALARM DISPLAYED. THE NURSE WAS IN THE INTENSIVE CARE UNIT (ICU) WITH THE PATIENT AND COULD NOT GET THE CONTROL UNIT (CU) TO RUN. TROUBLESHOOTING WAS PERFORMED; HOWEVER, THE ALARM PERSISTED. THE PATIENT WAS BROUGHT BACK TO THE CATHETERIZATION LAB FOR CATHETER REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14458997 ↗
• MalfunctionJul 25, 2019Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem

  ON (B)(6) 2019, AFTER 4 HOURS THERAPY, ICU NURSE CALLED WITH ALL MSD GROUPS DISABLED ALARM. PRIOR TO CALLING SHE HAD TRIED REBOOTING THE CONTROL UNIT AND CHECKING CONNECTIONS. EKOS REP WENT OVER TROUBLESHOOTING STEPS AND TRIED REBOOTING THE MACHINE AGAIN. THE ALARM PERSISTED. THE REP RECOMMENDED TO INFORM THE PHYSICIAN THAT THE ULTRASOUND WAS TURNED OFF AND THE CATHETER WAS RUNNING AS A STANDARD INFUSION CATHETER. THE PATIENT WAS REPORTED TO BE DOING GREAT. ON (B)(6) 2019, INVESTIGATION FOUND THAT THE MSD CABLE HAD SHORTED, LIKELY DUE TO DAMAGE AND FLUID INGRESS WHEN BEING PLACED IN THE PATIENT. WHILE NO PATIENT IMPACT OR ADVERSE EVENT WAS REPORTED, SERIOUS INJURY COULD OCCUR IF THIS MALFUNCTION WAS TO RECUR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8827399 ↗
• MalfunctionFeb 20, 2019Overheating of Device; Overheating of Device

  THIS IS A FOLLOW UP REPORT #1 TO UPDATE INFORMATION REPORTED IN H.10. REFER TO INITIAL REPORT FOR EVENT DESCRIPTION.

  Patient problems: Burn, Thermal

  MAUDE report 8355283 ↗
• MalfunctionSep 26, 2018Electrical Shorting; Material Deformation; Electrical Shorting; Material Deformation

  IT WAS REPORTED THAT A 40 CM EKOS CATHETER WAS USED TO TREAT A PATIENT ON (B)(6) 2018. THE CATHETER RAN FOR 26 HOURS AND 19 MINUTES WHEN A TEMPERATURE ALARM OCCURRED. THE USER REBOOTED THE CONTROL UNIT AND THE ALARM RESOLVED. A FEW HOURS LATER, THE USER REPORTED ANOTHER ALARM FOR NO ZONES ENABLED. THERAPY CONTINUED USING THE EKOS DEVICE AS A STANDARD INFUSION CATHETER. THE PATIENT WAS REPORTED AS "FINE" AND DID NOT EXPERIENCE ANY ADVERSE EVENTS. UPON INVESTIGATION OF THE RETURNED DEVICE ON 11 SEP 2018, DEVICE DAMAGE WAS FOUND.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7910843 ↗
• MalfunctionMay 25, 2018Detachment Of Device Component; Device Dislodged or Dislocated; Detachment Of Device Component; Device Dislodged or Dislocated

  EKOS WAS USED IN A PERIPHERAL ARTERIAL OCCLUSION CASE WITH AN ANTEGRADE FEMORAL ACCESS. IT WAS REPORTED THAT DURING REMOVAL OF THE EKOS CATHETER, RESISTANCE WAS NOTED AND UNDER FLUOROSCOPY, THE DISTAL MARKER BAND WAS SEEN IN THE SHEATH. IT WAS REMOVED WITH A SNARE AND THERE WAS NO PATIENT IMPACT REPORTED. IT WAS REPORTED THAT THE CATHETER AND SHEATH WERE KINKED DUE TO THE PATIENT BEING NONCOMPLIANT AND SITTING UP IN BED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7544069 ↗
• MalfunctionMar 28, 2018Fracture; Electrical Shorting; Fracture; Electrical Shorting

  IT WAS REPORTED THAT THE MSD FRACTURED INSIDE A PATIENT DURING EKOS TREATMENT OF A DEEP VEIN THROMBOSIS (DVT) ON (B)(6) 2018. IT WAS REPORTED THAT THERE WAS NO ISSUE WITH PLACEMENT OR ADVANCING THE CATHETER. IT WAS REPORTED THAT ANOTHER 40 CM CATHETER WAS PLACED WITH NO ISSUES WHICH RAN SUCCESSFULLY FOR APPROXIMATELY 19 HOURS OF THERAPY. THE FINAL PATIENT OUTCOME WAS GOOD. THE PATIENT WAS NOT HARMED AS A RESULT OF THE FRACTURED MSD. UPON INVESTIGATION OF THE RETURNED DEVICE, THE REPORTED COMPLAINT WAS CONFIRMED BY DEVICE DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7377667 ↗
• MalfunctionSep 14, 2017Kinked; Material Deformation; Kinked; Material Deformation

  A 106CM/40CM EKOSONIC CATHETER, (B)(4), WAS USED TO TREAT RIGHT LEG DEEP VEIN THROMBOSIS ON (B)(6) 2017. THE PHYSICIAN SUCCESSFULLY PLACED THE INFUSION CATHETER (IDDC, PART OF THE EKOSONIC CATHETER) IN THE PATIENT AND SUBSEQUENTLY PLACED ULTRASOUND CORE (MSD, MICROSONIC DEVICE) INSIDE THE IDDC. AFTER ABOUT 10-15 MINUTES THE EKOSONIC CONTROL UNIT, WHICH CONTROLS THE ULTRASOUND ENERGY, ALARMED WITH A DEVICE OVER TEMPERATURE ALARM. THE PHYSICIAN REMOVED THE MSD AND NOTICED IT WAS VERY SHORT. HE X-RAYED THE LIMB AND NOTICED A SECTION OF THE MSD WIRE STILL IN THE PATIENT. PHYSICIAN REMOVED EKOS CATHETER AND THE MSD SECTION WITH NO COMPLICATIONS. PHYSICIAN PLACED A NEW EKOSONIC CATHETER (50 CM) THE PATIENT COMPLETED THERAPY. UPON FOLLOW-UP, THE EKOS REPRESENTATIVE ADDED THAT THE PHYSICIAN NOTICED A SMALL KINK IN THE MSD WIRE WHEN HE OPENED THE PACKAGE.

  Patient problems: Missing Value Reason

  MAUDE report 6866742 ↗