EkoSonicRecalls & reported problems across all models

We found 11 models of EkoSonic by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 185 adverse event reports in the FDA's MAUDE database, received between Jan 19, 2017 and May 11, 2026 — classified as 4 deaths, 58 injuries, 123 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (32 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

EkoSonic recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. May 25, 2022Class IIOpen, Classified

   Product may be mislabeled.

   Z-1492-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. May 25, 2022Class IIOpen, Classified

   Product may be mislabeled.

   Z-1491-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported EkoSonic problems

EkoSonic models

11 models, most reported first. Each model has its own page with its reports, recalls and device details.

• EkoSonic® 6779-002

  Catheter, Continuous Flush
  1 recall4 deaths56 reports
• EkoSonic® 6795-002

  Catheter, Continuous Flush
  1 recall13 reports
• EkoSonic® 6795-007

  Catheter, Continuous Flush
  45 reports
• EkoSonic® 6779-007

  Catheter, Continuous Flush
  19 reports
• EkoSonic® 6779-003

  Catheter, Continuous Flush
  15 reports
• EkoSonic® 6795-006

  Catheter, Continuous Flush
  12 reports
• EkoSonic® 6779-006

  Catheter, Continuous Flush
  10 reports
• EkoSonic® 6795-005

  Catheter, Continuous Flush
  7 reports
• EkoSonic® 6779-005

  Catheter, Continuous Flush
  4 reports
• EkoSonic® 6779-001

  Catheter, Continuous Flush
  2 reports
• EkoSonic® 6779-004

  Catheter, Continuous Flush
  2 reports

Recent EkoSonic adverse event reports

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

• InjuryMay 11, 2026Break; Electrical /Electronic Property Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A DEVICE BREAK OCCURRED AND ADDITIONAL INTERVENTION WAS REQUIRED TO REMOVE AN UNRETRIEVED DEVICE FRAGMENT. ON (B)(6) 2026, A 106X12CM EKOSONIC DEVICE WAS SELECTED FOR THE TREATMENT OF A UNILATERAL PULMONARY EMBOLISM (PE). DURING THERAPY INITIATION (RUNTIME 00:00), AN E322 ERROR WAS DETECTED ON CHANNEL A. THE DEVICE OPERATED WITH NORMAL SALINE COOLANT AT 35 ML/HR AND TISSUE PLASMINOGEN ACTIVATOR (TPA) AT 1 MG/HR (31.2 ML/HR). INSERTION WAS REPORTED AS UNCOMPLICATED, AND VASCULAR ANATOMY WAS NOT TORTUOUS. TROUBLESHOOTING STEPS WERE UNDERTAKEN, BUT THE ALARM PERSISTED. RESOLUTION WAS ACHIEVED BY REPLACING THE ULTRASONIC CORE WIRE AND PERFORMING A HARD REBOOT. FOLLOWING THESE INTERVENTIONS, THE SYSTEM RESUMED NORMAL FUNCTION WITHOUT FURTHER ALARMS. NO PATIENT COMPLICATIONS OCCURRED DURING THE EVENT, AND THE PATIENT REMAINED IN GOOD CONDITION POST-PROCEDURE. ON (B)(6) 2026, FOLLOW-UP IMAGING REVEALED AN UNIDENTIFIED OBJECT WITHIN THE PATIENT'S VASCULATURE. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR RETRIEVAL. SUBSEQUENT PHYSICIAN EVALUATION IDENTIFIED THE OBJECT AS AN UNRETRIEVED DEVICE FRAGMENT (UDF) FROM THE EKOSONIC DEVICE USED IN THE (B)(6) PROCEDURE. THE UD

  Patient problems: Foreign Body In Patient

  MAUDE report 25140021 ↗
• MalfunctionAug 19, 2025Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE EKOS CATHETER WAS LEAKING AT THE DEVICE HUB OR MANIFOLD. AN EKOSONIC DEVICE WAS SELECTED FOR USE TO TREAT A BILATERAL PULMONARY EMBOLISM. TWO EKOS DEVICES WERE PLACED LATE IN THE EVENING. THE FOLLOWING MORNING, STAFF OBSERVED THAT ONE OF THE EKOS CATHETERS WAS LEAKING. THE LEAK WAS NOT REPORTED AS BEING CLINICALLY SIGNIFICANT. THE LEAK DID NOT IMPACT THE ADMINISTRATION OF ULTRASOUND OR LYTIC, AND THROMBUS RESOLUTION WAS ACHIEVED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED THAT THERE WAS A HOLE ON A PORTION OF THE INFUSION CATHETER THAT WOULD HAVE ENTERED THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22843838 ↗
• MalfunctionMay 16, 2025Output Problem; Output Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 21APR2025. IT WAS REPORTED THAT ERROR MESSAGES OCCURRED. A 135X50CM EKOSONIC ENDOVASCULAR DEVICE WAS SELECTED FOR USE IN THE TREATMENT OF DEEP VEIN THROMBOSIS. WHEN IN THE INTERVENTIONAL RADIOLOGY (IR) SUITE, A DEVICE TEMPERATURE TOO HIGH ERROR MESSAGE OCCURRED, SO THE PT3B CONSOLE WAS SWAPPED OUT FOR ANOTHER ONE. THE PATIENT HAD JUST BEEN TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) WHEN IT WAS OBSERVED THAT THE PT3B WAS NOT RUNNING. WHEN STARTED, IT TOOK APPROXIMATELY FIVE MINUTES FOR THE SAME DEVICE TEMPERATURE TOO HIGH ERROR MESSAGE TO OCCUR AGAIN. TROUBLESHOOTING WAS UNSUCCESSFUL. THE DEVICE WAS POWERED DOWN FOR FIVE MINUTES, BUT UPON TURNING BACK ON AND STARTING THERAPY, AN ALL MSD GROUPS DISABLED ERROR MESSAGE APPEARED. TROUBLESHOOTING WAS AGAIN UNSUCCESSFUL, SO IT WAS DECIDED THAT THE PROCEDURE WOULD BE COMPLETED WITHOUT ULTRASOUND USING THE CATHETER AS A STANDARD DRIP INFUSION CATHETER. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS REPORTED TO BE DOING WELL. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE ULTRASONIC CORE WAS SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22038879 ↗
• MalfunctionMay 14, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THE DEVICE WAS DIFFICULT TO REMOVE. THIS 106X12CM EKOSONIC CATHETER WAS SELECTED FOR USE DURING A BILATERAL PULMONARY EMBOLISM THROMBOLYSIS PROCEDURE. AFTER THROMBOLYSIS WAS COMPLETE, THE EKOS CATHETERS WERE BEING REMOVED, AND THE FIRST CATHETER WAS REMOVED WITHOUT INCIDENT. THE SECOND CATHETER WAS VERY DIFFICULT TO MOVE AND WAS NOTED TO BE STUCK. THE PHYSICIAN INCREASED THE PULLING PRESSURE SLIGHTLY, BUT THE PATIENT BEGAN TO COMPLAIN OF CHEST PAIN AND A PULLING FEELING IN THE CHEST AREA. THE ULTRASOUND CORE WIRE WAS REMOVED AND THE EKOS INFUSION CATHETER WAS FLUSHED BEFORE TRYING TO PULL AND REMOVE THE CATHETER AGAIN. THE PHYSICIAN INCREASED THE PULLING FORCE, THE CATHETER WAS REMOVED, AND THERE WERE NO PHYSICAL DEFECTS OBSERVED WITH THE CATHETER. THE PATIENT WAS NOTED TO BE DOING FINE AND WAS LATER DISCHARGED FROM THE HOSPITAL.

  Patient problems: Chest Pain

  MAUDE report 22018241 ↗
• InjuryMar 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SUBJECT EXPERIENCED RIGHT SIDED INGUINAL HEMATOMA WITH SCROTAL INVOLVEMENT REQUIRING PROLONGED HOSPITALIZATION AND MEDICATION. ON (B)(6) 2025, SUBJECT WAS RANDOMIZED TO THE STUDY. ANTICOAGULATION AND EKOS INDEX PROCEDURE WERE PERFORMED ON THE SAME DAY. TWO EKOS DEVICES WERE SUCCESSFULLY PLACED IN THE RIGHT PULMONARY ARTERY AND LEFT PULMONARY ARTERY. THERAPY WAS INITIATED VIA THE EKOS DEVICES AT A RATE OF 2MG/HR FOR A TOTAL DOSE OF 7 MG ACROSS BOTH CATHETERS ON SAME DAY. ON (B)(6) 2025, THE SUBJECT WAS NOTED TO HAVE INCREASING TENDERNESS AND HARD SWELLING AROUND RIGHT GROIN REGION WHERE THE VENOUS CATHETER SITE WAS ACCESSED. SUBJECT WAS ALSO NOTED TO HAVE INCREASED SWELLING AND PURPLE DISCOLORATION THAT WORSENED OVER A DAY. A CT OF ABDOMINAL AND PELVIS WAS PERFORMED WHICH REVEALED, SMALL FOCI OF ACTIVE BLEEDING IN THE SUBCUTANEOUS TISSUES OF THE RIGHT GROIN, ADJACENT RIGHT INGUINAL HEMATOMA EXTENDS INTO THE RIGHT SCROTUM AND TOWARDS THE RIGHT FLANK. BILATERAL CENTRAL AND SEGMENTAL PULMONARY EMBOLI WITH OVERALL DECREASED CLOT BURDEN WHEN COMPARED TO (B)(6) 2025. THE BLEED WAS DETERMINED TO BE VENOUS IN ORIGIN AND SHOULD RESPOND TO PRESSURE. APIXABAN WAS START

  Patient problems: Extravasation; Hematoma; Swelling/ Edema

  MAUDE report 21638098 ↗
• MalfunctionJan 27, 2025Break; Break

  IT WAS REPORTED THAT THE ULTRASONIC CORE BROKE. A 135CM X 50CM EKOSONIC ENDOVASCULAR DEVICE WAS SELECTED FOR USE IN A RIGHT LOWER EXTREMITY ULTRASOUND-ACCELERATED THROMBOLYSIS PROCEDURE FOR DEEP VEIN THROMBOSIS (DVT). DURING THE PROCEDURE INSIDE THE BODY, WHILE ATTEMPTING TO REMOVE AND REPOSITION THE CATHETER INTO A BETTER LOCATION, THE ULTRASONIC CORE BROKE INTO TWO PIECES. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21242097 ↗
• InjuryJan 16, 2025Material Twisted/Bent; Output Problem; Material Twisted/Bent; Output Problem

  IT WAS REPORTED THAT UNPLANNED SEDATION OCCURRED. A 135CM X 50CM EKOSONIC ENDOVASCULAR DEVICE WAS SELECTED FOR USE IN A UNILATERAL CASE TO TREAT A PERIPHERAL ARTERIAL OCCLUSION (PAO) IN THE RIGHT LEG. AFTER 4HOURS AND 30 MINUTES OF THERAPY RUNTIME, THE EKOS HELPLINE WAS CALLED DUE TO AN E311 NO TRANSDUCER GROUPS ENABLED ALARM ON CHANNEL B. IT WAS ALSO REPORTED THAT THE PATIENT WOKE UP AGITATED, CONFUSED, AND UNCOOPERATIVE. THE PATIENT ATTEMPTED TO GET OUT OF BED AND WALK. THEREFORE, THE PATIENT WAS SEDATED. IN AN ATTEMPT TO TROUBLESHOOT THE ALARM, THE UNIT WAS RESET, AND CONNECTIONS WERE CHECKED. SWAPPING THE DEVICE TO CHANNEL A AND A HARD REBOOT WERE BOTH UNSUCCESSFUL. SINCE TROUBLESHOOTING WAS UNSUCCESSFUL, THE OPTIONS WERE TO RUN THE CATHETER AS A STANDARD DRIP CATHETER OR HAVE THE PHYSICIAN COME BACK TO EXCHANGE THE CATHETER. THE PATIENT WAS IN AN AGITATED SLUMBER. NO FURTHER COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE ULTRASONIC CORE WAS KINKED UPON INSERTION. THE PROCEDURE WAS COMPLETED USING THE CATHETER AS A STANDARD DRIP CATHETER. THE CLOT WAS RESOLVED, AND THE PATIENT WAS DISCHARGED.

  Patient problems: Confusion/ Disorientation

  MAUDE report 21173328 ↗
• MalfunctionJan 14, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT THERE WAS AN E311 ERROR DURING THE INITIAL PROCEDURE. AN EKOSONIC ENDOVASCULAR DEVICE, 135X50CM WAS SELECTED FOR USE IN A UNILATERAL THROMBECTOMY PROCEDURE. THE EKOS DEVICE WAS PREPPED AND DEPLOYED IN THE USUAL FASHION WITHOUT DIFFICULTY. THE CATHETER WAS PLACED AND HOOKED UP TO ALL INFUSING FLUIDS. UPON CONNECTION OF THE EKOS DEVICE TO THE EKOS CU 4.0 CONSOLE, THERE WAS AN E311 ERROR ON THE CONSOLE. MULTIPLE TROUBLESHOOTING ATTEMPTS WERE MADE, BUT THE ERROR PERSISTED. THE EKOS DEVICE WAS PLUGGED INTO A PT3B, WHICH EXPERIENCED AN ERROR AS WELL. THE EKOS DEVICE WAS EXCHANGED, AND THE ISSUE WAS RESOLVED. THERE WERE NO REPORTED PATIENT COMPLICATIONS. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE ULTRASONIC CORE (USC) WAS FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21150041 ↗
• InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HI-PEITHO CLINICAL STUDY. IT WAS REPORTED THAT ISCHEMIC CEREBROVASCULAR ACCIDENT (CVA) OCCURRED, REQUIRING INTERVENTION. ON (B)(6) 2024, THE SUBJECT UNDERWENT TREATMENT WITH STUDY DEVICE: EKOSONIC ENDOVASCULAR DEVICE, 106X12CM. TWO EKOS CATHETERS WERE SUCCESSFULLY PLACED, ONE IN THE RIGHT LOWER LOBAR ARTERY AND ONE IN THE LEFT LOWER LOBAR ARTERY. THERAPY WAS INITIATED VIA THE EKOS DEVICE AT A RATE OF 2MG/HR FOR A TOTAL DOSE OF 7 MG ACROSS BOTH THE CATHETERS ON THE SAME DAY. ON (B)(6) 2024, THE SUBJECT WAS DIAGNOSED WITH ISCHEMIC CEREBROVASCULAR ACCIDENT (CVA). THE EVENT LED TO PROLONGATION OF HOSPITALIZATION AND INTRA-ARTERIAL THERAPY INTERVENTION.

  Patient problems: Ischemia Stroke

  MAUDE report 21126401 ↗
• InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ISCHEMIC CEREBROVASCULAR ACCIDENT (CVA) OCCURRED, REQUIRING INTERVENTION. ON (B)(6) 2024, THE SUBJECT UNDERWENT TREATMENT WITH STUDY DEVICE: EKOSONIC ENDOVASCULAR DEVICE, 106X12CM. TWO EKOS CATHETERS WERE SUCCESSFULLY PLACED, ONE IN THE RIGHT LOWER LOBAR ARTERY AND ONE IN THE LEFT LOWER LOBAR ARTERY. THERAPY WAS INITIATED VIA THE EKOS DEVICE AT A RATE OF 2MG/HR FOR A TOTAL DOSE OF 7 MG ACROSS BOTH THE CATHETERS ON THE SAME DAY. ON 17-DEC-2024, THE SUBJECT WAS DIAGNOSED WITH ISCHEMIC CEREBROVASCULAR ACCIDENT (CVA). THE EVENT LED TO PROLONGATION OF HOSPITALIZATION AND INTRA-ARTERIAL THERAPY INTERVENTION.IT WAS FURTHER REPORTED THAT ON (B)(6) 2024, THE EKOS CATHETERS WERE SUCCESSFULLY PLACED IN THE RIGHT FEMORAL VEIN, RIGHT LOWER LOBAR ARTERY AND LEFT LOWER LOBAR ARTERY. IN THE CONTEXT OF THE STUDY, THE PATIENT RECEIVED TREATMENT WITH EKOS AND ANTICOAGULATION USING HEPARIN. ON 17-DEC-2024, THE SUBJECT DEVELOPED ACUTE WORSENING OF NEUROLOGICAL FUNCTION, FOR WHICH CEREBRAL COMPUTED TOMOGRAPHY (CT) WAS PERFORMED. THIS SHOWED A M1 CLOT IN THE LEFT MIDDLE CEREBRAL ARTERY AREA. THERE WERE ALSO SIGNS OF OCCLUSION AND CLOTS IN THE LEFT COMMON CAROTID (LCC) AND INTERNAL CA

  Patient problems: Ischemia Stroke

  MAUDE report 21126352 ↗
• InjuryDec 11, 2024Output Problem; Output Problem

  IT WAS REPORTED THAT THE PATIENT HAD TO RETURN TO THE CATH LAB FOR DEVICE EXCHANGE. AN EKOSONIC ENDOVASCULAR DEVICE, 135X50CM WAS SELECTED FOR USE. DURING THERAPY IN THE ICU, THERE WAS AN "ALL MSD GROUPS DISABLED" ALARM ON THE PT3B. TROUBLESHOOTING WAS UNABLE TO RESOLVE THE ALARM. THE PATIENT WAS RETURNED TO THE CATH LAB AND THE EKOS DEVICE WAS EXCHANGED. THE ERROR WAS RESOLVED AND EKOS THERAPY CONTINUED. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20907535 ↗
• 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 ↗
• MalfunctionOct 24, 2024Leak/Splash; Obstruction of Flow; Leak/Splash; Obstruction of Flow

  IT WAS REPORTED THAT THERE WAS A DRUG LEAK AND OCCLUSION. AN EKOSONIC ENDOVASCULAR DEVICE, 106X24CM WAS SELECTED FOR USE IN A UNILATERAL THROMBOLYSIS PROCEDURE. AFTER SEVEN HOURS OF EKOS THERAPY, WHILE IN THE ICU, IT WAS OBSERVED THAT THERE WAS A WET SPOT IN THE PATIENT'S BED AND SOME BLOOD BACKING UP IN THE DRUG LUER. THE NURSE ATTEMPTED TO FLUSH THE CATHETER AND OBSERVED THAT FLUID SQUIRTED SIDEWAYS OUT OF THE DRUG INFUSION TUBING, BELOW THE HUB WHERE THE STOPCOCK WAS CONNECTED. THERE WAS A PINHOLE LEAK IN THE HUB OF THE DRUG INFUSION TUBING. THE LINE INTO THE PATIENT WAS COMPLETELY OCCLUDED. TROUBLESHOOTING WAS UNABLE TO RESOLVE THE ISSUE. THE TPA WAS RUN AT A SLOWER RATE TO BYPASS THE ISSUE AND THERAPY WAS COMPLETED IN THE MORNING. THROMBUS WAS RESOLVED. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20523485 ↗
• MalfunctionOct 14, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED VIA ATTACHED VOLUNTARY MEDWATCH/MAUDE REPORT LIST #MW5158934 THAT THERE WAS A DRUG LEAK. AN EKOSONIC ENDOVASCULAR DEVICE, 106X50CM WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN TPA ADMINISTRATION WAS STARTED, A SMALL LEAK WAS DISCOVERED IN THE CATHETER. NO FURTHER DETAILS WERE AVAILABLE, DESPITE REQUEST BY BOSTON SCIENTIFIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20441985 ↗
• MalfunctionOct 3, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THERE WAS A DRUG OCCLUSION. AN EKOSONIC ENDOVASCULAR DEVICE, 106X12CM WAS SELECTED FOR USE IN A BILATERAL THROMBOLYSIS PROCEDURE TO TREAT A PULMONARY EMBOLISM. THE EKOS DEVICE WAS PLACED IN THE LEFT PULMONARY ARTERY. DURING THE PROCEDURE, THERE WAS AN OCCLUSION IN THE DRUG LUMEN OF THE EKOS INFUSION CATHETER. AS A RESULT, EKOS THERAPY WAS DISCONTINUED WITH THIS DEVICE. THERE WAS NO REPORTED IMPACT TO THE PATIENT, AND THE PATIENT WAS REPORTED TO BE UNHARMED AS A RESULT OF THE DEVICE DEFICIENCY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20360347 ↗

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