Device, Neurovascular Embolization
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 §882.5950 (Neurology panel).
FDA MAUDE casebook
openFDA event book Device, Neurovascular Embolization MID-BOOK · MAUDE
#117 of 1000 · 26,211 reports · 1995–2026
- BOOK 26,211 reports
- RANK #117 of 1000
- DEATH 640 death-typed
- INJ 6,282 injury-typed
- MALF 19,139 malfunction
- SPAN 1995–2026
- PEAK 2017: 2,494
- PHOTO Tubes
Nearest event-volume peer: Tubes, Gastrointestinal (And Accessories) (139 report gap)
Device, Neurovascular Embolization sits #117 of 1000 among tracked device types with 26,211 MAUDE reports spanning 1995–2026. 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
Device, Neurovascular Embolization carries 73.0% MALFUNCTION-coded reports, 8.2pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 2.4% corpus 1.5% · above corpus mean (+0.9 pp)
- INJ 24.0% corpus 30.3% · below corpus mean (-6.3 pp)
- MALF 73.0% corpus 64.8% · above corpus mean (+8.2 pp)
Lead product-problem code Failure to Advance is 15% of coded problems · Lead manufacturer PENUMBRA, INC. accounts for 61% of manufacturer-tagged reports · Top event location is 49% of location-tagged rows .
Device, Neurovascular Embolization in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- System
System, Thermal Regulating
26,611 reports
- Test
Test, Time, Prothrombin
26,539 reports
- Wheelchair
Wheelchair, Mechanical
26,370 reports
- Device (this)
Device, Neurovascular Embolization
26,211 reports
- Tubes
Tubes, Gastrointestinal (And Accessories)
26,072 reports
- Prosthesis
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
25,951 reports
What this shows Device, Neurovascular Embolization carries 26,211 MAUDE reports, ranked #117 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 (545) held close to the prior two-year average of 560.
Related Entities for Device, Neurovascular Embolization
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Device, Neurovascular Embolization: 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 (26,211 here).
Similar death-typed counts
Nearest other device types by death-typed report count (640 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Device, Neurovascular Embolization 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 Device, Neurovascular Embolization; 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.