Intrasaccular Flow Disruption Device
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 Intrasaccular Flow Disruption Device LIGHT-BOOK · MAUDE
#697 of 1000 · 889 reports · 2019–2026
- BOOK 889 reports
- RANK #697 of 1000
- DEATH 34 death-typed
- INJ 393 injury-typed
- MALF 462 malfunction
- SPAN 2019–2026
- PEAK 2024: 262
- PHOTO Accessories, Catheter
Nearest event-volume peer: Accessories, Catheter (3 report gap)
Intrasaccular Flow Disruption Device sits #697 of 1000 among tracked device types with 889 MAUDE reports spanning 2019–2026. 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 →
Injury-coded reports run above the device-type norm
Intrasaccular Flow Disruption Device carries 44.2% INJURY-coded reports, 13.9pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 3.8% corpus 1.5% · above corpus mean (+2.3 pp)
- INJ 44.2% corpus 30.3% · above corpus mean (+13.9 pp)
- MALF 52.0% corpus 64.8% · below corpus mean (-12.9 pp)
Lead product-problem code Separation Failure is 29% of coded problems · Lead manufacturer MICROVENTION, INC. accounts for 80% of manufacturer-tagged reports · Top event location is 90% of location-tagged rows .
Intrasaccular Flow Disruption Device in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Probe
Probe, Radiofrequency Lesion
897 reports
- Flow Cytometr…
Flow Cytometric Reagents And Accessories.
896 reports
- Laparoscopic…
Laparoscopic Contraceptive Tubal Occlusion Device
893 reports
- Unit
Unit, Cautery, Thermal, Ac-Powered
893 reports
- Intrasaccular… (this)
Intrasaccular Flow Disruption Device
889 reports
- Accessories
Accessories, Catheter
886 reports
What this shows Intrasaccular Flow Disruption Device carries 889 MAUDE reports, ranked #697 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 (225) held close to the prior two-year average of 191.
Related Entities for Intrasaccular Flow Disruption Device
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Intrasaccular Flow Disruption Device: 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 (889 here).
Similar death-typed counts
Nearest other device types by death-typed report count (34 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Intrasaccular Flow Disruption Device 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 Intrasaccular Flow Disruption Device; 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.