Epic™ Vascular H74939200103020Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729804987), received between Oct 31, 2018 and Oct 31, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Material Deformation” (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.
Most reported problems
Device problems
- Material Deformation1
- Positioning Problem1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 31, 2018Material Deformation; Positioning Problem; Material Deformation; Positioning Problem
IT WAS REPORTED THAT STENT SHORTENED AFTER DEPLOYMENT. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED SUBCLAVIAN ARTERY WHICH WAS VERY CLOSE TO THE AORTIC BIFURCATION. A 10X30X120CM EPIC VASCULAR STENT WAS ADVANCED FOR TREATMENT. INITIALLY IT WAS REPORTED THAT WHEN THE STENT WAS PLACED, NEARLY HALF OF THE STENT CAME OUT FROM THE SUBCLAVIAN ARTERY TO THE AORTIC ARCH. FOLLOW-UP CONFIRMED THAT THERE WAS NO ISSUE WITH THE STENT MIGRATING, BUT THERE WAS A PLACEMENT PROBLEM. THE STENT WAS SHORT 3CM AND THE PHYSICIAN WAS UNABLE TO ADJUST THE LOCATION. THE STENT WAS SOMEHOW BROUGHT UP TO THE ILIAC ARTERY AND AN EXPRESS LD STENT WAS PLACED OVER THE EPIC STENT. THE EXPRESS LD STENT SUFFICIENTLY EXTENDED UP TO EXTERNAL ILIUM AND THE EPIC STENT WAS FIXED IN THE ILIAC BIFURCATION. A 10X40MM EPIC STENT WAS PLACED IN THE SUBCLAVIAN ARTERY AND THE PROCEDURE WAS COMPLETED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8025118 ↗
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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