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Epic BiliaryRecalls & reported problems across all models

Boston Scientific Corporation · 11 models in the FDA device registry

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
95
Deaths reported
0
Injuries reported
23
Recalls
0

We found 11 models of Epic Biliary by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 95 adverse event reports in the FDA's MAUDE database, received between Feb 2, 2018 and Jan 26, 2026 — classified as 23 injuries, 72 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (39 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Reports received per month, all models

Nov 2023: 4 reportsDec 2023: 2 reportsJan 2024: 1 reportsFeb 2024: 0 reportsMar 2024: 1 reportsApr 2024: 3 reportsMay 2024: 0 reportsJun 2024: 1 reportsJul 2024: 1 reportsAug 2024: 0 reportsSep 2024: 1 reportsOct 2024: 1 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 1 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 2 reportsMay 2025: 0 reportsJun 2025: 1 reportsJul 2025: 1 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 4 reportsDec 2025: 0 reportsJan 2026: 1 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520264
Last 36 months. The most recent month may be incomplete.

Most reported Epic Biliary problems

Device problems

  • Activation, Positioning or Separation Problem39
  • Material Deformation20
  • Difficult to Advance16
  • Difficult to Remove16
  • Positioning Failure16
  • Premature Activation15
  • Detachment of Device or Device Component11
  • Positioning Problem11

Patient problems

  • No Clinical Signs, Symptoms or Conditions69
  • No Consequences Or Impact To Patient22
  • Foreign Body In Patient4
  • Insufficient Information1
  • No Code Available1
  • No Known Impact Or Consequence To Patient1

Epic Biliary models

11 models, most reported first. Each model has its own page with its reports, recalls and device details.

Recent Epic Biliary adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

Other Boston Scientific Corporation products

All Boston Scientific Corporation devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page