EkoSonic® 6779-003Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00858593006141), received between Sep 11, 2017 and Jul 2, 2024 — classified as 6 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJul 2, 2024Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  IT WAS REPORTED THAT THE HUB LEAKED REQUIRING ADDITIONAL INTERVENTION. TWO EKOSONIC ENDOVASCULAR DEVICE, 106X18CM WERE SELECTED FOR USE. WHILE IN THE CARDIAC CATHETERIZATION LAB (CCL), THE FIRST CATHETER WAS PLACED WITHIN 15 MINUTES. THE SECOND CATHETER PLACEMENT TOOK APPROXIMATELY AN HOUR TO SEAT IT IN THE LEFT LOBE OF THE LUNG. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) WHERE THE PUMPS WERE CONNECTED. UPON INSPECTION, IT WAS NOTED THAT THE LEFT CATHETER WAS LEAKING AT THE DRUG PORT. UPON FURTHER INSPECTION, THE PLASTIC WAS BRITTLE AND BROKE OFF WHERE IT CONNECTED TO THE STOP COCK. THE PATIENT WAS BROUGHT BACK TO THE CCL AND THE CATHETER WAS SWAPPED SUCCESSFULLY. THE PUMPS WERE HOOKED UP AND THE PATIENT WAS TRANSFERRED BACK TO THE ICU. AFTER 20 MINUTES THE NEW LEFT CATHETER ALSO STARTED TO LEAK. THE LEAK WAS DURABOND AND TAPED AND APPEARED TO BE HOLDING. THE PATIENT DID NOT RECEIVE THE ADEQUATE AMOUNT OF LYTIC AND WAS BROUGHT BACK FOR AN ADDITIONAL ANGIO AND RIGHT HEART CATHETERIZATION. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19656378 ↗
• MalfunctionApr 22, 2024Break; Output Problem; Break; Output Problem

  IT WAS REPORTED THAT THE CATHETER WAS FRACTURED AND DETACHED. THIS 106X18CM EKOSONIC ENDOVASCULAR DEVICE WAS SELECTED FOR USE IN A UNILATERAL ARTERIAL LEG PROCEDURE. DURING THERAPY, AN E311 ALARM WAS OBSERVED, WHICH COULD NOT BE RESOLVED DESPITE TROUBLESHOOTING. THE CATHETER WAS USED AS A STANDARD INFUSION CATHETER WITHOUT THE USE OF ULTRASOUND TO COMPLETE THE PROCEDURE. IT WAS FURTHER REPORTED THAT WHEN THE PATIENT WAS BROUGHT TO THE CATHETERIZATION LABORATORY AND THE EKOSONIC ENDOVASCULAR DEVICE WAS REMOVED, THE DISTAL PORTION OF THE ULTRASOUND WIRE WAS BROKEN AWAY FROM THE WIRE. IT WAS STABLE WITHIN THE INFUSION CATHETER, AND NOTHING WAS LOST. THERE WAS NO CONSEQUENCE TO THE PATIENT; CLOT LYSIS HAD BEEN ACHIEVED. THE REMAINING CLOT WAS REMOVED USING ANGIOJET, AND THE UNDERLYING LESIONS WERE TREATED WITH TWO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19158859 ↗
• InjuryFeb 9, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BOTH THE DRUG AND COOLANT LUERS WERE LEAKING, AND AS A RESULT, THE PATIENT WAS RETURNED TO THE CATHETERIZATION LAB FOR DEVICE EXCHANGE. AN EKOSONIC ENDOVASCULAR DEVICE, 106X18CM WAS SELECTED FOR USE IN A BILATERAL PULMONARY EMBOLISM CASE. APPROXIMATELY 90 MINUTES INTO EKOS THERAPY, IT WAS OBSERVED THAT THERE WAS FLUID LEAKING OUT OF THE INFUSION CATHETER ON CHANNEL B, WHERE THE RUBBER CONNECTION MET THE CATHETER, NEAR THE WHITE HUB. THE PHYSICIAN FLUSHED THE DRUG AND COOLANT LUERS WITH SALINE TO CHECK WHICH LUER WAS LEAKING. IT WAS DETERMINED THAT BOTH LUERS WERE LEAKING AT THE SITE WHEN FLUSHED. THE PHYSICIAN ELECTED TO BRING THE PATIENT BACK TO THE CATHETERIZATION LAB AND EXCHANGE THE EKOS DEVICE FOR AN EKOS +. THE PATIENT WAS REPORTED TO BE DOING FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18675921 ↗
• InjuryDec 4, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE EKOS DEVICE WAS LEAKING. AN EKOSONIC ENDOVASCULAR DEVICE, 106X18CM WAS SELECTED FOR USE TO TREAT A PULMONARY EMBOLISM. WHEN THE PHYSICIAN ATTEMPTED TO FLUSH THE EKOS CATHETER, IT WAS OBSERVED THAT THE HUB WAS PULLING AIR. IT WAS NOT REPORTED WHETHER THE PHYSICIAN WAS ATTEMPTING TO FLUSH COOLANT OR LYTIC. THE EKOS DEVICE WAS EXCHANGED TO RESOLVE THE ISSUE. IT WAS NOT REPORTED AT WHAT POINT DURING EKOS THERAPY THE DEVICE EXCHANGE OCCURRED. THERE WERE NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18258867 ↗
• InjuryMay 3, 2022Break; Break

  IT WAS REPORTED THAT A CATHETER FRACTURE OCCURRED. AN EKOSONIC ENDOVASCULAR DEVICE WAS SELECTED FOR THE TREATMENT OF DEEP VEIN THROMBOSIS (DVT) IN THE RIGHT LEG. DURING THERAPY, AN ALARM WAS RECEIVED ON THE CONTROL UNIT INDICATING POOR CONNECTION BETWEEN THE INFUSION CATHETER AND THE ULTRASONIC CORE. DURING TROUBLESHOOTING, ANOTHER ALARM INDICATING THAT THE RADIO-FREQUENCY BOARD IS UNABLE TO COMMUNICATE WITH THE CONNECTOR INTERFACE CABLE WAS RECEIVED. THE ALARMS WERE UNRESOLVED THROUGH TROUBLESHOOTING, SO THERAPY WAS CONTINUED USING THE CATHETER AS A STANDARD INFUSION CATHETER. THE FOLLOWING DAY, DURING A RECHECK OF THE DVT, THE ULTRASOUND WIRE WAS FOUND TO BE BROKEN OFF THE TRANSITION OF THE TRANSDUCERS. THE FRACTURED ULTRASOUND WIRE WAS SNARED OUT OF THE POPLITEAL VEIN. THE TREATMENT WAS COMPLETED WITHOUT ANY INTERRUPTION OF TPA DELIVERY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14268802 ↗
• MalfunctionJan 16, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ON 27 DECEMBER 2019, EKOS REP WAS INFORMED THAT THEY HAD A CATHETER "THAT BROKE" DURING A PE CASE LAST WEEK. THE ACCOUNT PLACED ANOTHER CATHETER AND COMPLETED THE CASE WITH NO ISSUE. THE CUSTOMER EXPLAINED THAT PRIOR TO INSERTION, THE RADIOPAQUE TIP WAS IN PLACE BUT THEN FELL OFF BEFORE THE CATHETER COULD BE USED ON THE CASE. THEY PULLED ANOTHER CATHETER AND WORKED FINE. THE PATIENT HAD A GOOD OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9598303 ↗
• MalfunctionDec 13, 2019Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem

  ON (B)(6) 2019, AFTER 11 HOURS AND 4 MINUTES OF THERAPY FOR A PERIPHERAL ARTERIAL OCCLUSION (PAO) CASE, THE CUSTOMER CALLED WITH AN ALL MSD GROUPS DISABLED ALARM. ICU NURSE STATED THAT SHE WAS ONCE ABLE TO RESTART THERAPY, BUT CONTROL UNIT (CU) ALARMED AGAIN WITH THE ABOVE ALARM. AFTER TROUBLESHOOTING AND RESTARTING THE CU, SHE WAS ABLE TO GET YELLOW LIGHT FLASHING. AFTER 3 MINS ALL MSD DISABLED ALARM APPEARED AGAIN. EKOS REPRESENTATIVE SUGGESTED TO GET ANOTHER CONTROL UNIT AND TO INFORM THE PROCEDURAL PHYSICIAN THAT THE ULTRASOUND THERAPY WAS NOT RUNNING. THE NURSE INFORMED THAT THE PATIENT WAS TO GO BACK TO CATH LAB AROUND 2:00 PM THAT DAY FOR A FOLLOW-UP PROCEDURE. PATIENT STATUS WAS REPORTED AS GOOD. AFTER AN HOUR, THE NURSE CALLED BACK WITH A NEW CU ON HAND. SHE DISCONNECTED THE INTELLIGENT DRUG DELIVERY CATHETER (IDDC) AND MICROSONIC DEVICE (MSD) AND INSERTED INTO NEW CIC AND CU. SHE WAS ABLE TO GET THE YELLOW LIGHT FLASHING FOR 2 MINUTES, HOWEVER ALL MSD GROUPS DISABLED ALARM APPEARED. EKOS REPRESENTATIVE ADVISED THE NURSE TO INFORM THE PROCEDURAL PHYSICIAN THAT ULTRASOUND THERAPY WAS NOT POSSIBLE WITH THAT CATHETER, BUT THE CATHETER CAN BE RAN AS A CATHETER DIRECTED THROMBO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9469752 ↗
• MalfunctionNov 5, 2019Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem

  ON (B)(6) 2019, 6 HOURS AND 31 MINUTES INTO THERAPY, ACCOUNT CALLED WITH AN ALTERNATING WHITE C RED THERMOMETER/BLUE THERMOMETER ALARM. EKOS CATHETER WAS PLACED TO TREAT A BILATERAL PULMONARY EMBOLISM (PE). ULTRASOUND WAS PAUSED. AFTER TROUBLESHOOTING, THE STAFF RECONNECTED AND STARTED ULTRASOUND AND YELLOW LIGHT FLASHING. THE CONNECTOR INTERFACE CABLE (CIC) WAS ON TOP OF THE BLANKETS, DRESSING WAS CLEAN AND INTACT, AND IV TUBING/ROLLER CLAMPS/STOPCOCKS WERE ALL OPEN. PATIENT WAS STABLE AND ON A VENTILATOR. DURING FOLLOW-UP, THE CUSTOMER STATED WHEN TRYING TO PULL OUT ULTRASOUND WIRE IT WAS STUCK AND STRETCHED. ON (B)(6), TWO CATHETERS WERE RETURNED WITHOUT THE MARKER BANDS. UPON FOLLOW-UP, THE CUSTOMER INFORMED THAT "THE PATIENT DID WELL" AND THERE WAS "NOTHING LEFT IN THE PATIENT" BECAUSE THEY WOULD HAVE SEEN THE MARKER BAND ON FLUOROSCOPY. ONE INTELLIGENT DRUG DELIVERY CATHETER (IDDC) WAS DIFFICULT TO REMOVE AND EXTENDED AND STRETCHED DURING REMOVAL. THE ACCOUNT STATED THAT THEY DID NOT THINK THAT HEMOSTASIS VALVE WAS USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9281020 ↗
• MalfunctionOct 22, 2019Unexpected Shutdown

  EKOS CATHETER STOPPED WORKING DURING THERAPY AND MACHINE SHUT DOWN. MEDICATION THERAPY STILL INFUSING. NO HARM TO PT. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9225320 ↗
• MalfunctionSep 20, 2019Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  EKOS DISTRIBUTOR REPORTED THAT AFTER 12 HOURS OF TREATMENT, THE CATHETER WAS REPLACED DUE TO A LEAK FROM THE DRUG LUMEN. THE CATHETER WAS BEING PLACED TO TREAT A PULMONARY EMBOLISM (PE). THE PATIENT RECEIVED THE TARGETED AMOUNT OF LYTIC AND WAS REPORTED TO BE STABLE. WHILE NO PATIENT IMPACT OR ADVERSE EVENT WAS REPORTED, THE PATIENT UNDERWENT A SECOND PROCEDURE TO REPLACE THE DEVICE FOR PE TREATMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9100898 ↗
• MalfunctionMar 27, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  EKOS WAS USED IN A BILATERAL PE CASE FOR A TOTAL OF 14.5 HOURS. THE DEVICE WAS INVESTIGATED ON FEBRUARY 26, 2019 AND WAS FOUND TO HAVE THE MARKER BAND MISSING. THE ACCOUNT WAS CONTACTED ABOUT THE MISSING MARKER BAND AND REPORTED THAT THE BAND WAS IN THE SHEATH WHILE THE SHEATH WAS STILL IN THE PATIENT. THE CUSTOMER USED A MERIT PRELUDE PRO SHEATH. THE CASE WAS COMPLETED WITH NO OTHER INTERVENTION OR INJURY TO THE PATIENT. NOTE THAT THE CUSTOMER WAS INFORMED THAT THE STYLE USED WAS AGAINST THE INSTRUCTIONS PROVIDED IN THE EKOS IFU.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8457463 ↗
• InjuryJan 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A (B)(6) FEMALE PATIENT WAS TREATED WITH EKOS FOR A BILATERAL PE ON (B)(6) 2017 (DURATION AND DOSE OF TREATMENT WAS NOT REPORTED). THE PATIENT DEVELOPED VTE (VENOUS THROMBOEMBOLISM); ARTERIAL OCCLUSION OF THE LEFT LOWER EXTREMITY ON (B)(6) 2017. THE PATIENT REQUIRED HOSPITALIZATION AND PERCUTANEOUS THROMBECTOMY. THE SAE RESOLVED ON (B)(6) 2017. THIS EVENT WAS NOT REPORTED TO THE MANUFACTURER BY THE TREATING PHYSICIAN AT THE TIME OF THE EVENT. THIS PATIENT WAS ENROLLED IN A RETROSPECTIVE STUDY (B)(6) (SUBJECT (B)(6)). THE INVESTIGATOR ASSESSED THE VTE (VENOUS THROMBOEMBOLISM); ARTERIAL OCCLUSION OF THE LEFT LOWER EXTREMITY AS SERIOUS AND NOT RELATED TO THE EKOS DEVICE BUT PROBABLY RELATED TO THE INTERVENTIONAL PROCEDURE, THROMBOLYTIC DRUG AND ANTICOAGULANT DRUG.

  Patient problems: Thrombosis

  MAUDE report 8217997 ↗
• MalfunctionAug 9, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  AN EKOS CATHETER WAS USED TO TREAT A PATIENT WITH A BILATERAL PE ON (B)(6) 2018. IT WAS REPORTED THAT THE DEVICE WOULD NOT INFUSE. DURING THE INVESTIGATION OF THE RETURNED EKOS CATHETER 171220091-005 ON 18 JUL 2018, IT WAS DISCOVERED THAT THE DISTAL MARKER BAND WAS MISSING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7767442 ↗
• InjuryNov 1, 2017Cut In Material; Device Handling Problem; Cut In Material; Device Handling Problem

  IT WAS REPORTED ON (B)(6) 2017 THAT TWO CATHETERS (12 CM LEFT AND 18 CM RIGHT) WERE PLACED ON (B)(6) 2017 FOR A BILATERAL PE CASE. IT WAS REPORTED THAT ON THE MORNING OF (B)(6) 2017, THE PHYSICIAN DISCOVERED THAT THE RIGHT SIDE CATHETER WAS LEAKING AND IT PREVENTED THE PATIENT FROM RECEIVING TREATMENT IN THE RIGHT PULMONARY ARTERY. THE PATIENT WAS BROUGHT BACK TO THE LAB AND THE PHYSICIAN TOOK A REPEAT ANGIOGRAM OF THE RIGHT PULMONARY ARTERY AND NOTED THAT IT WAS STILL FULL OF THROMBUS. THE PHYSICIAN DOES NOT BELIEVE THAT THE PATIENT RECEIVED ANY TPA IN THE RIGHT PULMONARY ARTERY. IT WAS REPORTED THAT THE PATIENT IS STABLE AND HAS TOLERATED THE TREATMENT TO THIS POINT. THE PLAN IS TO GO ANOTHER 12 HOURS ON THE RIGHT SIDE, OR TREAT SYMPTOMATICALLY DEPENDING UPON THE PATIENT'S RESPONSE. THE CATHETER WAS RETURNED FOR EVALUATION.

  Patient problems: Radiation Exposure, Unintended; Therapeutic Response, Decreased

  MAUDE report 6994345 ↗
• MalfunctionSep 11, 2017Bent; Device Issue; Material Deformation; Bent; Device Issue; Material Deformation

  A 106CM/18 CM EKOSONIC CATHETER (SN: (B)(4)) WAS USED TO TREAT A PATIENT WITH PERIPHERAL ARTERIAL OCCLUSION ON (B)(6)2017. AFTER SUCCESSFULLY PLACING THE INFUSION CATHETER (PART OF THE EKOSONIC DEVICE) IN THE PATIENT, THE TREATING PHYSICIAN ATTEMPTED TO PLACE THE ULTRASOUND CORE WIRE (MICROSONIC DEVICE, MSD) WHERE IT FAILED TO TRACK THROUGH THE INFUSION CATHETER. THE PHYSICIAN SUCCESSFULLY PLACED A NEW EKOSONIC CATHETER AND WAS ABLE TO SUCCESSFULLY COMPLETE THERAPY.

  Patient problems: Missing Value Reason; No Consequences Or Impact To Patient

  MAUDE report 6856732 ↗