Epic™ Vascular H74939200071020Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729805540), received between Nov 17, 2017 and Dec 15, 2023 — classified as 1 injury, 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
- Fracture1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 15, 2023Material Deformation; Material Deformation
IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 7X100X120 EPIC VASCULAR STENT WAS SELECTED FOR USE IN A LOWER EXTREMITY STENTING. HOWEVER, DURING UNPACKING, IT WAS NOTED THAT THE STENT LOOKED DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18334858 ↗MalfunctionMar 8, 2022Fracture; Fracture
IT WAS REPORTED THAT STENT FRACTURE OCCURRED. A 7X100X120 EPIC VASCULAR STENT WAS SELECTED FOR USE TO TREAT THE ILIAC ARTERY. HOWEVER, AFTER OPENING THE PACKAGE, DURING PREPARING THE DEVICE TO FLUSH; A STRUT WAS NOTICED TO BE FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13700373 ↗InjuryNov 17, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
IT WAS REPORTED THAT THE STENT MOVED DURING DEPLOYMENT. A 7X100X120 EPIC¿ VASCULAR STENT WAS SELECTED FOR A PROCEDURE IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). DURING DEPLOYMENT, THE STENT MOVED ON THE PHYSICIAN WHICH RESULTED IN ADDITIONAL STENTING OF ANOTHER EPIC¿. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S CONDITION WAS FINE POST PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7041318 ↗
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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