Epic™ Vascular H74939200101020Recalls & reported problems
Boston Scientific Corporation · Self-Expanding Stent System · Class 3
All models of Epic Vascular (50)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729805106), received between Dec 17, 2021 and Oct 1, 2024 — classified as 2 malfunctions.
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
- Failure to Advance1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 1, 2024Failure to Advance; Material Deformation; Failure to Advance; Material Deformation
IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MILDLY CALCIFIED EXTERNAL ILIAC ARTERY (EIA). A 10X100X120 EPIC VASCULAR STENT WAS SELECTED FOR STENTING VIA IPSILATERAL APPROACH. DURING THE PROCEDURE, IT WAS NOTED THAT THE STENT COULD NOT CROSS THE LESION. CONSEQUENTLY, THE STENT WAS FLARED OUT ON THE UNDEPLOYED STENT DURING REMOVAL. THE STENT WAS REMOVED INTACT FROM THE PATIENT'S BODY, AND THE PROCEDURE WAS COMPLETED BY REPLACING THE STENT. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20345493 ↗MalfunctionDec 17, 2021Entrapment of Device; Entrapment of Device
IT WAS REPORTED THAT CATHETER ENTRAPMENT ON GUIDEWIRE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ILIAC VEIN WITH AORTIC OCCLUSIVE DISEASE. A 10X100X120 EPIC VASCULAR STENT WAS SUCCESSFULLY DEPLOYED. HOWEVER, WHEN THE PHYSICIAN WAS RETRACTING THE STENT CATHETER TO REMOVE FROM THE BODY, THE DELIVERY CATHETER STAYED ON THE WIRE. THE WIRE AND THE DELIVERY CATHETER WERE SUCCESSFULLY REMOVED. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13028287 ↗
Other STENT, ILIAC devices
- Cordis S.M.A.R.T. Control Vascular Stent System C10040MLCordis US Corp. · STENT, ILIAC1 recall3 reports
- Absolute Pro 1012534-100Abbott Vascular Inc. · STENT, ILIAC51 reports
- Protégé™ GPS™ SERB65-09-60-80Ev3, Inc · STENT, ILIAC1 recall0 reports
- Cordis S.M.A.R.T. Control Vascular Stent System C09060MLCordis US Corp. · STENT, ILIAC1 recall0 reports
- Absolute Pro 1012535-100Abbott Vascular Inc. · STENT, ILIAC1 death41 reports
- Omnilink Elite 1012631-39Abbott Vascular Inc. · STENT, ILIAC27 reports
- Omnilink Elite 1012632-29Abbott Vascular Inc. · STENT, ILIAC25 reports
- Absolute Pro 1012536-100Abbott Vascular Inc. · STENT, ILIAC21 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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