Stents, Drains And Dilators For The Biliary Ducts
Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.
OpenFDA device adverse-event casebook.
FDA Class II (moderate risk, special controls required), regulated under 21 CFR §876.5010 (Gastroenterology, Urology panel).
FDA MAUDE casebook
openFDA event book Stents MID-BOOK · MAUDE
#99 of 1000 · 33,655 reports · 1993–2026
- BOOK 33,655 reports
- RANK #99 of 1000
- DEATH 359 death-typed
- INJ 9,786 injury-typed
- MALF 23,207 malfunction
- SPAN 1993–2026
- PEAK 2021: 2,297
- PHOTO Wire, Guide, Catheter
Nearest event-volume peer: Wire, Guide, Catheter (33 report gap)
Stents, Drains And Dilators For The Biliary Ducts sits #99 of 1000 among tracked device types with 33,655 MAUDE reports spanning 1993–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →
Malfunction reports run above the device-type norm
Stents carries 69.0% MALFUNCTION-coded reports, 4.1pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 1.1% corpus 1.5% · near corpus mean (-0.4 pp)
- INJ 29.1% corpus 30.3% · below corpus mean (-1.2 pp)
- MALF 69.0% corpus 64.8% · above corpus mean (+4.1 pp)
Lead product-problem code Material Rupture is 16% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 40% of manufacturer-tagged reports · Top event location is 53% of location-tagged rows .
Stents in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Wire
Wire, Guide, Catheter
33,688 reports
- Stents (this)
Stents, Drains And Dilators For The Biliary Ducts
33,655 reports
- Pump
Pump, Infusion, Elastomeric
33,422 reports
- Detector And…
Detector And Alarm, Arrhythmia
33,370 reports
- Pump
Pump, Infusion, Pca
32,663 reports
- Prosthesis
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
32,652 reports
What this shows Stents, Drains And Dilators For The Biliary Ducts carries 33,655 MAUDE reports, ranked #99 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports in 2025 (1,945) held close to the prior two-year average of 1,782.
Related Entities for Stents, Drains And Dilators For The Biliary Ducts
Top Manufacturers
Event Locations
Compare BOSTON SCIENTIFIC CORPORATION vs BOSTON SCIENTIFIC - GALWAY →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Stents: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.
Similar report volume
Nearest other device types by FDA MAUDE report count (33,655 here).
Similar death-typed counts
Nearest other device types by death-typed report count (359 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Stents are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.
Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Stents; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.