Agent, Injectable, Embolic
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 MAUDE casebook
openFDA event book Agent, Injectable, Embolic LIGHT-BOOK · MAUDE
#405 of 1000 · 3,062 reports · 2001–2026
- BOOK 3,062 reports
- RANK #405 of 1000
- DEATH 259 death-typed
- INJ 1,897 injury-typed
- MALF 898 malfunction
- SPAN 2001–2026
- PEAK 2023: 433
- PHOTO Lenses
Nearest event-volume peer: Lenses, Soft Contact, Extended Wear (1 report gap)
Agent, Injectable, Embolic sits #405 of 1000 among tracked device types with 3,062 MAUDE reports spanning 2001–2026. 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 sit below the device-type norm
Agent, Injectable, Embolic carries 29.3% MALFUNCTION-coded reports, 35.5pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 8.5% corpus 1.5% · above corpus mean (+7.0 pp)
- INJ 62.0% corpus 30.3% · above corpus mean (+31.7 pp)
- MALF 29.3% corpus 64.8% · below corpus mean (-35.5 pp)
Lead product-problem code Adverse Event Without Identified Device or Use Problem is 43% of coded problems · Lead manufacturer MICRO THERAPEUTICS, INC. DBA EV3 accounts for 74% of manufacturer-tagged reports · Top event location is 63% of location-tagged rows .
Agent, Injectable, Embolic in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Prosthesis
Prosthesis, Esophageal
3,094 reports
- Test
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
3,089 reports
- Accelerator
Accelerator, Linear, Medical
3,068 reports
- Lenses
Lenses, Soft Contact, Extended Wear
3,063 reports
- Agent (this)
Agent, Injectable, Embolic
3,062 reports
- Prosthesis
Prosthesis, Elbow, Constrained, Cemented
3,057 reports
What this shows Agent, Injectable, Embolic carries 3,062 MAUDE reports, ranked #405 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 fell to 177 in 2025, down from an average of 341 in the two years before.
Related Entities for Agent, Injectable, Embolic
Top Manufacturers
Event Locations
Compare MICRO THERAPEUTICS, INC. DBA EV3 vs EV3 NEUROVASCULAR →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Agent, Injectable, Embolic: 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 (3,062 here).
Similar death-typed counts
Nearest other device types by death-typed report count (259 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Agent, Injectable, Embolic 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 Agent, Injectable, Embolic; 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.