EKOS +Recalls & reported problems across all models

We found 4 models of EKOS + by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 6 adverse event reports in the FDA's MAUDE database, received between Oct 18, 2023 and May 2, 2025 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (3 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 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

EKOS + 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. Oct 13, 2022Open, Classified

   Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU.

   Z-0149-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported EKOS + problems

EKOS + models

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

• EKOS™ EKOS Control Unit 4.0

  Catheter, Continuous Flush
  1 recall1 report
• EKOS™ + H74939605106120

  Catheter, continuous flush
  3 reports
• EKOS™ + H74939605135160

  Catheter, continuous flush
  1 report
• EKOS™ + H74939605135200

  Catheter, continuous flush
  1 report

Recent EKOS + adverse event reports

The 6 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2025Crack; Fluid/Blood Leak

  ONE OF THE CORDS FOR THE EKOS [EKOSONIC ENDOVASCULAR SYSTEM] HAD A CRACK IN IT AND WAS LEAKING FLUID AT ONE OF THE CONNECTIONS. WE HAD TO OPEN A NEW PRODUCT, TAKE OUT THE BROKEN ONE AND RE-INSERT THE NEW ONE. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21950048 ↗
• MalfunctionAug 28, 2024Output Problem; Output Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. DURING A BILATERAL EKOS PROCEDURE, THE CONTROL UNIT 4.0 STARTED ALARMING WITH AN E311 ERROR ON BOTH CATHETERS. TROUBLESHOOTING WAS PERFORMED BUT WAS UNABLE TO RESOLVE THE ALARM. THE EKOS THERAPY WAS DISCONTINUED APPROXIMATELY THREE HOURS AFTER THE TREATMENT STARTED. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20089455 ↗
• InjuryJul 22, 2024Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DRUG PORT LEAKED, REQUIRING AN ADDITIONAL DEVICE. ONE 106CM 12 CM EKOS PLUS CATHETER AND ONE 135CM 16 CM EKOS PLUS CATHETER WERE SELECTED FOR USE. DURING THE PROCEDURE, BOTH EKOS CATHETERS WERE PLACED IN THE PATIENT AND HOOKED UP TO THE APPROPRIATE PUMPS. AFTER EVERYTHING WAS CONNECTED, IT WAS DETERMINED THAT ONE OF THE CATHETERS HAD MOVED INSIDE THE PATIENT AND NEEDED TO BE REPOSITIONED. ALL LINES WERE THEN DISCONNECTED, THE CATHETER WAS REPOSITIONED AND EVERYTHING WAS HOOKED BACK UP AGAIN. THE PATIENT WAS MOVED TO THE INTENSIVE CARE UNIT (ICU) AND IT WAS NOTICED THAT BOTH DRUG LUMEN PORTS WERE LEAKING FLUID AT THE CONNECTOR. THE PATIENT WAS BROUGHT BACK TO THE LAB AND THE ORIGINAL CATHETERS WERE REMOVED AND TWO NEW EKOS CATHETERS WERE PLACED WITHOUT ISSUE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19801112 ↗
• InjuryJul 22, 2024Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DRUG PORT LEAKED, REQUIRING AN ADDITIONAL DEVICE. ONE 106CM 12 CM EKOS PLUS CATHETER AND ONE 135CM 16 CM EKOS PLUS CATHETER WERE SELECTED FOR USE. DURING THE PROCEDURE, BOTH EKOS CATHETERS WERE PLACED IN THE PATIENT AND HOOKED UP TO THE APPROPRIATE PUMPS. AFTER EVERYTHING WAS CONNECTED, IT WAS DETERMINED THAT ONE OF THE CATHETERS HAD MOVED INSIDE THE PATIENT AND NEEDED TO BE REPOSITIONED. ALL LINES WERE THEN DISCONNECTED, THE CATHETER WAS REPOSITIONED AND EVERYTHING WAS HOOKED BACK UP AGAIN. THE PATIENT WAS MOVED TO THE INTENSIVE CARE UNIT (ICU) AND IT WAS NOTICED THAT BOTH DRUG LUMEN PORTS WERE LEAKING FLUID AT THE CONNECTOR. THE PATIENT WAS BROUGHT BACK TO THE LAB AND THE ORIGINAL CATHETERS WERE REMOVED AND TWO NEW EKOS CATHETERS WERE PLACED WITHOUT ISSUE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19793615 ↗
• MalfunctionJan 9, 2024Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  IT WAS REPORTED THAT THE DRUG PORT WAS CRACKED AND LEAKING. AN EKOS+ DEVICE WAS SELECTED FOR USE TO TREAT A HEAVY ARTERIAL THROMBUS BURDEN. THE DEVICE WAS PLACED WITHOUT ISSUE AND WAS INTENDED TO DELIVERY 0.5MG OF LYTIC THERAPY FOR 24 HOURS. THE PATIENT WAS TRANSFERRED TO THE ICU. AT 9:00PM, A POOL OF SEROSANGUINOUS FLUID WAS OBSERVED AROUND THE CATHETER. UPON FURTHER INSPECTION, IT WAS NOTED THAT THERE WAS A LEAK AT THE DRUG CONNECTION TO THE STOPCOCK. A CRACK ON THE CATHETER WAS OBSERVED AT THIS LOCATION. THE CRACK WAS UNSUCCESSFULLY ATTEMPTED TO BE SEALED. TO BYPASS THE ISSUE, THE TPA LINE WAS CONNECTED TO THE COOLANT LINE TO CONTINUE EKOS THERAPY. NO FURTHER ISSUES WERE REPORTED WITH THE DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18477100 ↗
• MalfunctionOct 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 28SEP2023. AN EKOS+ ENDOVASCULAR DEVICE WAS RETURNED TO THE COMPLAINT INVESTIGATION SITE WITHOUT AN ASSOCIATED COMPLAINT. DEVICE ANALYSIS REVEALED THAT THE COOLANT AND DRUG LUERS WERE CRACKED AND LEAKING. BASED ON THE CONDITION OF THE RETURNED DEVICE, THE DEVICE WAS USED DURING A PROCEDURE. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17962443 ↗

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