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2026 data FDA MAUDE openFDA FDA Class II

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 Class II (moderate risk, special controls required), regulated under 21 CFR §870.3300 (Cardiovascular panel).

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FDA MAUDE casebook

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

#177 of 1000 · 14,423 reports · 1992–2026

  • BOOK 14,423 reports
  • RANK #177 of 1000
  • DEATH 239 death-typed
  • INJ 3,309 injury-typed
  • MALF 10,794 malfunction
  • SPAN 1992–2026
  • PEAK 2025: 1,597
  • PHOTO Pulse Generator

Nearest event-volume peer: Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) (71 report gap)

Device, Vascular, For Promoting Embolization sits #177 of 1000 among tracked device types with 14,423 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 →

Malfunction reports run above the device-type norm

Device, Vascular, For Promoting Embolization carries 74.8% MALFUNCTION-coded reports, 10.0pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.7% corpus 1.5% · near corpus mean (+0.2 pp)
  • INJ 22.9% corpus 30.3% · below corpus mean (-7.4 pp)
  • MALF 74.8% corpus 64.8% · above corpus mean (+10.0 pp)

Lead product-problem code Separation Failure is 16% of coded problems · Lead manufacturer MEDOS INTERNATIONAL SARL accounts for 24% of manufacturer-tagged reports · Top event location is 57% 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 14,423 MAUDE reports, ranked #177 of 1000.

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

Event Types

Malfunction 10,794 (74.8%)
Injury 3,309 (22.9%)
Death 239 (1.7%)
Other 73 (0.5%)
8 (0.1%)

Patient Outcomes

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

10,573 (69.9%)
Required Intervention 2,228 (14.7%)
Other 720 (4.8%)
R 417 (2.8%)
Hospitalization 324 (2.1%)
Death 221 (1.5%)
Life Threatening 192 (1.3%)
S 101 (0.7%)
H 99 (0.7%)
O 77 (0.5%)
Disability 74 (0.5%)
L 70 (0.5%)
D 20 (0.1%)
Congenital Anomaly 3 (0.0%)

Top Product Problems

Separation Failure 2,700
Detachment of Device or Device Component 1,815
Stretched 1,604
Adverse Event Without Identified Device or Use Problem 1,491
Physical Resistance/Sticking 1,322
Failure to Advance 980
Premature Separation 933
Break 899
Detachment Of Device Component 561
Material Deformation 505
Entrapment of Device 498
Migration 484
Difficult to Advance 472
Premature Activation 446
Migration or Expulsion of Device 439
Difficult to Remove 436
Unraveled Material 284
Positioning Problem 254
Material Twisted/Bent 241
Material Protrusion/Extrusion 216

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: 1,029

Reports in 2025 (1,597) held close to the prior two-year average of 1,453.

Related Entities for Device, Vascular, For Promoting Embolization

Top Manufacturers

MEDOS INTERNATIONAL SARL 2,652
MICRO THERAPEUTICS, INC. DBA EV3 2,382
BOSTON SCIENTIFIC CORPORATION 1,597
MICROVENTION, INC. 1,494
BOSTON SCIENTIFIC - CORK 860
MEDTRONIC MEXICO S. DE R.L. DE CV 824
COOK INC 551
MEDTRONIC MEXICO 404
ABBOTT MEDICAL 346

Event Locations

8,278 (57.4%)
I 5,698 (39.5%)
HOSPITAL 312 (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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Device, Vascular, For Promoting 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 (14,423 here).

Pulse Generator 14,494 Set, I.V. Fluid Transfer 14,331 Lens, Multifocal Intraocular 14,298 Appliance, Fixation, Spinal Interlaminal 14,567

Similar death-typed counts

Nearest other device types by death-typed report count (239 here), distinct from the volume row.

Sv70 Ventilator 247 Bed, Manual 251 Catheter, Steerable 251 Integrated Continuous Glucose Monitoring Sy… 226

Read our methodology - how this data is sourced, computed, and verified.

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.