ELUVIA™ H74939294701570Recalls & reported problems
Boston Scientific Corporation · Drug-Eluting Vascular Stent System · Class 3 · Implant
All models of ELUVIA (13)
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 08714729876687), received between Mar 30, 2026 and Mar 30, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Entrapment of Device” (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
- Entrapment of Device1
- Premature Activation1
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.
MalfunctionMar 30, 2026Entrapment of Device; Premature Activation
IT WAS REPORTED THAT STENT PREMATURE DEPLOYMENT OCCURRED. A 7X150, 75 CM ELUVIA SELF-EXPANDING STENT WAS USED DURING AN ANGIOGRAM WITH INTERVENTION FOR ARTERIAL DISEASE. DEPLOYMENT ISSUES OCCURRED; PREMATURE DEPLOYMENT WAS NOTED AND THE STENT BECAME STUCK ON THE WIRE, PROLONGING THE PROCEDURE. IT WAS NOTED THAT THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THIS DEVICE AND THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24735320 ↗
Other Stent, superficial femoral artery, drug-eluting devices
- ELUVIA™ H74939294601210Boston Scientific Corporation · Stent, superficial femoral artery, drug-eluting1 death80 reports
- Zilver PTX G24890Cook Ireland Ltd · Stent, superficial femoral artery, drug-eluting1 recall24 reports
- ELUVIA™ H74939294701210Boston Scientific Corporation · Stent, superficial femoral artery, drug-eluting58 reports
- Zilver PTX G38482Cook Ireland Ltd · Stent, superficial femoral artery, drug-eluting57 reports
- Zilver PTX G24895Cook Ireland Ltd · Stent, superficial femoral artery, drug-eluting1 recall3 reports
- ELUVIA™ H74939294601510Boston Scientific Corporation · Stent, superficial femoral artery, drug-eluting50 reports
- Zilver PTX G38483Cook Ireland Ltd · Stent, superficial femoral artery, drug-eluting32 reports
- ELUVIA™ H74939294701510Boston Scientific Corporation · Stent, superficial femoral artery, drug-eluting31 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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