Epic™ Vascular H74939200096070Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729805830), received between Feb 14, 2019 and Jul 6, 2022 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Migration1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 6, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT SHEATH DETACHMENT OCCURRED. A 9X60X120MM AND A 9X60X75MM EPIC ILIAC STENTS WERE SUCCESSFULLY DEPLOYED. HOWEVER, DURING REMOVAL OF THE STENT FROM THE SHEATH, THE PHYSICIAN NOTICED THAT THE INNER SHEATH ON ONE WAS INTACT AND STILL ON THE WIRE AND WAS REMOVED OVER THE WIRE FROM THE BODY. THE SECOND ONE WAS INTACT AND WAS REMOVED FROM THE BODY AS ONE PIECE. IT WAS NOTICED AFTER REMOVAL THAT IT WAS STARTING TO SEPARATE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14940929 ↗InjuryFeb 14, 2019Migration; Migration
IT WAS REPORTED THAT STENT MIGRATION OCCURRED. THE TARGET LESION WAS LOCATED IN A FISTULA. A NON-BSC BALLOON WAS ATTEMPTED TO BE ADVANCED AND WAS UNSUCCESSFUL. A 10X60X75 EPIC VASCULAR STENT WAS DEPLOYED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE STENT MIGRATED FORWARD AND MISSED THE LESION. THE PHYSICIAN OPENED ANOTHER 9X60X75 EPIC VASCULAR STENT AND THE SAME THING HAPPENED. THE STENTS MIGRATED IN THE FISTULA AND WERE LEFT INSIDE THE PATIENT'S BODY AS RETRIEVING THE STENTS WOULD CAUSE MORE DAMAGE TO THE FISTULA. THE CASE WAS COMPLETED SUCCESSFULLY WITH A SUBOPTIMAL RESULT. NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8341027 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page