EkoSonic® 6795-005Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00858593006295), received between Jul 11, 2017 and Dec 9, 2024 — classified as 2 injuries, 5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 9, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE EKOS DEVICE WAS LEAKING AND REQUIRED DEVICE EXCHANGE. AN EKOSONIC ENDOVASCULAR DEVICE, 135X30CM WAS SELECTED FOR USE. AT SOME POINT DURING THE PROCEDURE OR THERAPY, IT WAS OBSERVED THAT THE EKOS DEVICE WAS LEAKING. IT WAS NOT REPORTED WHETHER THE LEAK WAS ATTRIBUTED TO LYTIC OR COOLANT. THE EKOS DEVICE WAS EXCHANGED FOR A NON-BOSTON SCIENTIFIC INFUSION CATHETER. NO FURTHER INFORMATION WAS PROVIDED, DESPITE REQUEST BY BOSTON SCIENTIFIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20880092 ↗
• MalfunctionJan 31, 2023Entrapment of Device; Difficult to Advance; Entrapment of Device; Difficult to Advance

  IT WAS REPORTED THAT ENTRAPMENT ON THE GUIDEWIRE OCCURRED. AN EKOSONIC ENDOVASCULAR DEVICE, 135X30CM WAS SELECTED FOR USE IN THE THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND THE PROFUNDA ARTERY. THERE WAS DIFFICULTY ADVANCING THE INFUSION CATHETER (IC) INTO THE PROFUNDA ARTERY, AS WELL AS DIFFICULTY ADVANCING THE ULTRASONIC CORE (USC) INTO THE IC. THE PARTIALLY INSERTED USC WAS REMOVED, AND A NON-BSC GUIDEWIRE WAS INSERTED TO BETTER SEAT THE IC DEEPER WITHIN THE ARTERY. AFTER ADVANCING THE IC FURTHER INTO THE ARTERY TO THE TARGET LESION, THE GUIDEWIRE WAS UNABLE TO BE REMOVED FROM THE IC. BOTH THE GUIDEWIRE AND IC WERE REMOVED FROM THE PATIENT TOGETHER. THE CATHETER WAS EXCHANGED FOR ANOTHER TYPE OF CATHETER IN ORDER TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16273478 ↗
• InjuryJan 4, 2023Break; Electrical /Electronic Property Problem; Break; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE ULTRASONIC CORE BROKE. A 135X30CM EKOSONIC ENDOVASCULAR DEVICE WAS SELECTED FOR USE IN A UNILATERAL ARTERIAL PROCEDURE. ON THE SECOND DAY RUNNING, THE CATHETER WAS EXCHANGED OUT FOR A NEW CATHETER IN THE OPERATING ROOM. AFTER LESS THAN 30 MINUTES OF THERAPY RUNTIME, E311 AND E300 ALARMS OCCURRED. THE HELPLINE WAS CALLED, AND TROUBLESHOOTING WAS UNSUCCESSFUL. OPTIONS WERE GIVEN TO EITHER RUN AS CATHETER DIRECTED THROMBOLYSIS (CDT) OR TO SWITCH OUT THE CATHETER FOR A NEW ONE. ULTIMATELY, THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM TO SWITCH OUT THE CATHETER. WHEN REMOVING THE CATHETER, IT WAS OBSERVED UNDER FLUOROSCOPY THAT A PORTION OF THE ULTRASONIC CORE WAS FLOATING AROUND IN THE PATIENT'S INFERIOR VENA CAVA. THE PHYSICIAN WAS ABLE TO SNARE AND RETRIEVE THE DEVICE FRAGMENT. A NEW CATHETER WAS PLACED, AND THE PATIENT WAS STABLE. THE PATIENT WAS OKAY AND TREATED FOR ADDITIONAL DISEASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16098948 ↗
• MalfunctionAug 24, 2022Leak/Splash; Material Integrity Problem; Material Twisted/Bent; Leak/Splash; Material Integrity Problem; Material Twisted/Bent

  IT WAS REPORTED THAT THE CATHETER HAD A LEAK AND APPEARS TO HAVE BEEN DAMAGED. THIS EKOSONIC ENDOVASCULAR DEVICE HAD THERAPY RUNNING ON TWO CATHETERS FOR THIS PATIENT. AT 13 HOURS 35 MINUTES INTO TREATMENT, THERE WAS A LEAK NOTED ON CHANNEL A (DISTAL TO THE WHITE MANIFOLD). THE CATHETER WAS KINKED AND HAD A HOLE THAT APPEARED TO HAVE BEEN DAMAGED. THE FLUID COMING OUT OF CATHETER WAS BLOODY, AND COULD NOT BE DETERMINED IF IT WAS TPA OR COOLANT. ALL THERAPY WAS DISCONTINUED ON CHANNEL A, AND THE CATHETER WOULD NEED TO BE REPLACED BEFORE RESUMING THERAPY. GOOD FAITH EFFORT REGARDING THE RESOLUTION WAS REQUESTED, HOWEVER HAS NOT BEEN OBTAINED AT THIS TIME. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15283201 ↗
• MalfunctionAug 24, 2022Temperature Problem; Temperature Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 04AUG2022. IT WAS REPORTED THAT AN ERROR MESSAGE OCCURRED. AN 135X30CM EKOSONIC CATHETER WAS SELECTED FOR USE TO TREAT A UNILATERAL DEEP VEIN THROMBUS. THE THERAPY RUN TIME WITH THE CATHETER WAS 13 HOURS AND FIVE MINUTES. AT THAT POINT, AN ALARM OCCURRED WHICH INDICATED THAT THE DEVICE TEMPERATURE WAS TOO HIGH. TROUBLESHOOTING WAS PERFORMED BY THE NURSE AND WAS RESOLVED. HOWEVER, THE SAME ERROR OCCURRED AGAIN. ADDITIONAL TROUBLESHOOTING WAS PERFORMED BUT THAT DID NOT RESOLVE THE ISSUE. THE NURSE CONSULTED WITH THE PHYSICIAN WHO DECIDED TO TURN OFF THE EKOS ULTRASOUND AND RUN THE CATHETER AS A SIMPLE INFUSION CATHETER. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS. HOWEVER, DEVICE ANALYSIS REVEALED A FRACTURED CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15282690 ↗
• MalfunctionApr 29, 2019Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem

  ON (B)(6) 2019, A HELPLINE CALL REPORTED THE CU ALARMING WITH CODE "ALL MSD DISABLED" AFTER10 HOURS AND 50 MINUTES OF THERAPY. THE ALARM COULD NOT BE RESOLVED OVER THE PHONE WITH THE EKOS REPRESENTATIVE. THE CALLER WAS INSTRUCTED TO ALERT THE PHYSICIAN THAT CATHETER WOULD HAVE TO BE USED AS A STANDARD INFUSION CATHETER. FINAL PATIENT OUTCOME WAS REPORTED AS GREAT. THERE WAS COMPLETE CLOT CLEARANCE AND THE PHYSICIAN WAS VERY HAPPY WITH THE RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8560724 ↗
• MalfunctionJul 11, 2017Kinked; Device Handling Problem; Kinked; Device Handling Problem

  EKOS FIELD REP RECEIVED AN EMAIL COMPLAINT REPORT FROM THE PHYSICIAN'S ASSISTANT ABOUT THIS INCIDENCE. THE COMPLAINT INDICATED THAT THE TREATING PHYSICIAN WAS UNABLE TO ADVANCE THE MICROSONIC DEVICE (MSD) IN ILIO FEMORAL ARTERY AND SUBSEQUENTLY ENCOUNTERED DIFFICULTY IN REMOVING BOTH CATHETER AND MSD FOR REPLACEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6704561 ↗