EKOS™ + H74939605106120Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00191506015466), received between Oct 18, 2023 and May 2, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Crack” (1 report).

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 3 most recent of 3 reports, 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 ↗
• 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 ↗
• 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 ↗