2026 data FDA MAUDE openFDA

Device, Vascular, For Promoting 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 MAUDE casebook

openFDA event book Device, Vascular, For Promoting Embolization MID-BOOK · MAUDE

#178 of 1000 · 13,654 reports · 1992–2026

  • BOOK 13,654 reports
  • RANK #178 of 1000
  • DEATH 231 death-typed
  • INJ 3,175 injury-typed
  • MALF 10,168 malfunction
  • SPAN 1992–2026
  • PEAK 2025: 1,597
  • PHOTO Lens

Nearest event-volume peer: Lens, Multifocal Intraocular (30 report gap)

Device, Vascular, For Promoting Embolization sits #178 of 1000 among tracked device types with 13,654 MAUDE reports spanning 1992–2026. 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 1.7% corpus 1.5% · near corpus mean (+0.2 pp)
  • INJ 23.3% corpus 30.4% · below corpus mean (-7.2 pp)
  • MALF 74.5% corpus 64.5% · above corpus mean (+10.0 pp)

Lead product-problem code Separation Failure is 17% of coded problems · Lead manufacturer MEDOS INTERNATIONAL SARL accounts for 23% of manufacturer-tagged reports · Top event location is 55% of location-tagged rows .

Device, Vascular, For Promoting Embolization in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Device, Vascular, For Promoting Embolization carries 13,654 MAUDE reports, ranked #178 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 10,168 (74.5%)
Injury 3,175 (23.3%)
Death 231 (1.7%)
Other 72 (0.5%)
8 (0.1%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

10,021 (69.6%)
Required Intervention 2,141 (14.9%)
Other 680 (4.7%)
R 408 (2.8%)
Hospitalization 311 (2.2%)
Death 215 (1.5%)
Life Threatening 190 (1.3%)
S 100 (0.7%)
H 96 (0.7%)
Disability 74 (0.5%)
O 72 (0.5%)
L 70 (0.5%)
D 18 (0.1%)
Congenital Anomaly 3 (0.0%)

Top Product Problems

Separation Failure 2,525
Detachment of Device or Device Component 1,646
Stretched 1,470
Adverse Event Without Identified Device or Use Problem 1,292
Physical Resistance/Sticking 1,203
Premature Separation 828
Failure to Advance 822
Break 738
Material Deformation 443
Migration 442
Detachment Of Device Component 437
Entrapment of Device 436
Difficult to Advance 402
Premature Activation 351
Difficult to Remove 317
Migration or Expulsion of Device 305
Unraveled Material 247
Positioning Problem 240
Material Twisted/Bent 237
Material Protrusion/Extrusion 182

Yearly Trend

92
1992: 1
93
1993: 2
94
1994: 3
95
1995: 2
96
1996: 22
97
1997: 14
98
1998: 20
99
1999: 10
00
2000: 6
01
2001: 8
02
2002: 78
03
2003: 13
04
2004: 10
05
2005: 35
06
2006: 19
07
2007: 21
08
2008: 14
09
2009: 40
10
2010: 61
11
2011: 102
12
2012: 137
13
2013: 244
14
2014: 159
15
2015: 337
16
2016: 437
17
2017: 736
18
2018: 1,066
19
2019: 1,185
20
2020: 1,167
21
2021: 1,444
22
2022: 1,498
23
2023: 1,371
24
2024: 1,535
25
2025: 1,597
26
2026: 260

Related Entities for Device, Vascular, For Promoting Embolization

Event Locations

7,514 (55.0%)
I 5,698 (41.7%)
HOSPITAL 307 (2.2%)
UNKNOWN 87 (0.6%)
NO INFORMATION 25 (0.2%)
OTHER 15 (0.1%)
INVALID DATA 6 (0.0%)
HOME 1 (0.0%)
NOT APPLICABLE 1 (0.0%)

Compare MEDOS INTERNATIONAL SARL vs MICRO THERAPEUTICS, INC. DBA EV3 →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Device, Vascular, For Promoting Embolization, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (13,654 here).

Similar death-typed counts

Nearest other device types by death-typed report count (231 here), distinct from the volume row.

Disclaimer: MAUDE figures for Device, Vascular, For Promoting 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, Vascular, For Promoting 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.