EKOS™ + H74939605135200Recalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00191506015527), received between Jan 9, 2024 and Jan 9, 2024 — classified as 1 malfunction.
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
- Leak/Splash1
- Material Deformation1
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.
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 ↗
Other Catheter, continuous flush devices
- PROWLER SELECT 606-S255XMedos International Sàrl · Catheter, continuous flush2 deaths980 reports
- PhenomTM 27 Catheter FG15150-0615-1SMicro Therapeutics, Inc. · Catheter, continuous flush2 deaths139 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page