Dilator, Esophageal
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 §876.5365 (Gastroenterology, Urology panel).
FDA MAUDE casebook
openFDA event book Dilator, Esophageal LIGHT-BOOK · MAUDE
#310 of 1000 · 5,224 reports · 1993–2026
- BOOK 5,224 reports
- RANK #310 of 1000
- DEATH 16 death-typed
- INJ 453 injury-typed
- MALF 4,735 malfunction
- SPAN 1993–2026
- PEAK 2018: 396
- PHOTO Expander
Nearest event-volume peer: Expander, Surgical, Skin Graft (16 report gap)
Dilator, Esophageal sits #310 of 1000 among tracked device types with 5,224 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
Dilator, Esophageal carries 90.6% MALFUNCTION-coded reports, 25.8pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.3% corpus 1.5% · below corpus mean (-1.2 pp)
- INJ 8.7% corpus 30.3% · below corpus mean (-21.6 pp)
- MALF 90.6% corpus 64.8% · above corpus mean (+25.8 pp)
Lead product-problem code Burst Container or Vessel is 19% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 43% of manufacturer-tagged reports · Top event location is 55% of location-tagged rows .
Dilator, Esophageal in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- System
System, X-Ray, Tomography, Computed
5,243 reports
- Sterilizer
Sterilizer, Chemical
5,242 reports
- Expander
Expander, Surgical, Skin Graft
5,240 reports
- Dilator (this)
Dilator, Esophageal
5,224 reports
- Light
Light, Surgical, Ceiling Mounted
5,203 reports
- Prosthesis
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
5,172 reports
What this shows Dilator, Esophageal carries 5,224 MAUDE reports, ranked #310 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 (284) held close to the prior two-year average of 294.
Related Entities for Dilator, Esophageal
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Dilator, Esophageal: 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 (5,224 here).
Similar death-typed counts
Nearest other device types by death-typed report count (16 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Dilator, Esophageal 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 Dilator, Esophageal; 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.