EKOS™ + H74939605135160Recalls & reported problems
Boston Scientific Corporation · Endovascular Device · Class 2
All models of EKOS + (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00191506015510), received between Jul 22, 2024 and Jul 22, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Leak/Splash” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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 ↗
Other Catheter, continuous flush devices
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- MarathonTM 105-5056Micro Therapeutics, Inc. · Catheter, continuous flush124 reports
- MarksmanTM FA-55150-1030Micro Therapeutics, Inc. · Catheter, continuous flush109 reports
- Renegade™ HI-FLO™ Kit M001183020Boston Scientific Corporation · Catheter, continuous flush109 reports
- EkoSonic® 6779-002Boston Scientific Corporation · Catheter, Continuous Flush1 recall4 deaths56 reports
- Chameleon CH08-40-75USMozarc Medical US LLC · Catheter, continuous flush2 recalls4 reports
- RebarTM 105-5081-153Micro Therapeutics, Inc. · Catheter, continuous flush2 deaths102 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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