Epic™ Vascular H74939200081270Recalls & reported problems
Boston Scientific Corporation · Self-Expanding Stent System · Class 3
All models of Epic Vascular (50)
Data updated Oct 16, 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 08714729805595), received between May 7, 2021 and Mar 19, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Activation, Positioning or Separation Problem1
- Difficult to Advance1
- Entrapment of Device1
- Positioning Problem1
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.
MalfunctionMar 19, 2024Activation, Positioning or Separation Problem; Positioning Problem; Activation, Positioning or Separation Problem; Positioning Problem
IT WAS REPORTED THAT THE STENT WAS DIFFICULT TO POSITION AND PARTIALLY DEPLOYED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MILD CALCIFIED EXTERNAL ILIAC ARTERY. AN 8X120X75 EPIC VASCULAR STENT WAS ADVANCED FOR TREATMENT. DURING STENT DEPLOYMENT, IT WAS FOLDED INSIDE THE DEPLOYED STENT, AND THE SECOND HALF OF THE STENT WAS DEPLOYED LIKE IT WAS PUSHED FORWARD. STENT DISTAL END WAS THEN ADVANCED AND DEPLOYED TO A COMPLETELY DIFFERENT POSITION FROM WHERE IT WAS RETRACTED. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18936137 ↗MalfunctionMay 7, 2021Entrapment of Device; Difficult to Advance; Entrapment of Device; Difficult to Advance
IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED ILIAC ARTERY. AN 8X120X75 EPIC VASCULAR STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHEN THE DEVICE WAS ADVANCED MIDWAY INTO THE LESION, IT WAS NOT FLOWING WELL WITH THE WIRE AND SEVERE RESISTANCE WAS NOTED. EVENTUALLY, THE GUIDE WIRE GOT STUCK, SO THE STENT WAS REMOVED TOGETHER WITH THE GUIDE WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11790480 ↗
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
- Cordis S.M.A.R.T. Control Vascular Stent System C09060MLCordis US Corp. · STENT, ILIAC1 recall0 reports
- Protégé™ GPS™ SERB65-09-60-80Ev3, Inc · 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
- Omnilink Elite 1012631-59Abbott 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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