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2026 data FDA MAUDE openFDA FDA Class II

Agents, Embolic, For Treatment Of Uterine Fibroids

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 Agents LIGHT-BOOK · MAUDE

#910 of 1000 · 477 reports · 2001–2026

  • BOOK 477 reports
  • RANK #910 of 1000
  • DEATH 18 death-typed
  • INJ 239 injury-typed
  • MALF 34 malfunction
  • SPAN 2001–2026
  • PEAK 2005: 61
  • PHOTO Enzyme Immunoassay

Nearest event-volume peer: Enzyme Immunoassay, Digoxin (1 report gap)

Agents, Embolic, For Treatment Of Uterine Fibroids sits #910 of 1000 among tracked device types with 477 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

Agents carries 7.1% MALFUNCTION-coded reports, 57.7pp below 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 50.1% corpus 30.3% · above corpus mean (+19.8 pp)
  • MALF 7.1% corpus 64.8% · below corpus mean (-57.7 pp)

Lead product-problem code Unknown (for use when the device problem is not known) is 51% of coded problems · Lead manufacturer BOSTON SCIENTIFIC - CORK accounts for 56% of manufacturer-tagged reports · Top event location is 44% of location-tagged rows .

Agents in the event-volume neighbourhood

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

reports

What this shows Agents, Embolic, For Treatment Of Uterine Fibroids carries 477 MAUDE reports, ranked #910 of 1000.

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

Event Types

Injury 239 (50.1%)
Other 184 (38.6%)
Malfunction 34 (7.1%)
Death 18 (3.8%)
2 (0.4%)

Patient Outcomes

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

Other 281 (49.3%)
Hospitalization 67 (11.8%)
58 (10.2%)
O 39 (6.8%)
Required Intervention 35 (6.1%)
R 25 (4.4%)
Death 18 (3.2%)
S 14 (2.5%)
L 12 (2.1%)
Disability 11 (1.9%)
Life Threatening 6 (1.1%)
H 3 (0.5%)
Congenital Anomaly 1 (0.2%)

Top Product Problems

Unknown (for use when the device problem is not known) 236
Adverse Event Without Identified Device or Use Problem 75
Insufficient Device Problem Information 50
Device remains implanted 32
Device Issue 14
Migration or Expulsion of Device 11
Therapy Delivered to Incorrect Body Area 8
Device Operates Differently Than Expected 6
Break 5
Device Contamination with Chemical or Other Material 4
Reaction 4
Improper or Incorrect Procedure or Method 3
Clumping in Device or Device Ingredient 2
Detachment Of Device Component 2
Entrapment of Device 2
Failure to Deliver 2
Failure to Infuse 2
Leak/Splash 2
Mechanical Jam 2
Patient-Device Incompatibility 2

Yearly Trend

01
2001: 1
02
2002: 11
03
2003: 60
04
2004: 45
05
2005: 61
06
2006: 44
07
2007: 46
08
2008: 23
09
2009: 11
10
2010: 24
11
2011: 16
12
2012: 21
13
2013: 9
14
2014: 15
15
2015: 16
16
2016: 14
17
2017: 11
18
2018: 7
19
2019: 4
20
2020: 1
21
2021: 4
22
2022: 20
23
2023: 3
24
2024: 1
25
2025: 3
26
2026: 6

Reports rose to 3 in 2025, up from an average of 2 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Agents, Embolic, For Treatment Of Uterine Fibroids

Top Manufacturers

BOSTON SCIENTIFIC - CORK 35
BOSTON SCIENTIFIC CORPORATION 24
UNK 4

Event Locations

212 (44.4%)
UNKNOWN 198 (41.5%)
I 40 (8.4%)
HOME 20 (4.2%)
HOSPITAL 4 (0.8%)
NO INFORMATION 1 (0.2%)
NOT APPLICABLE 1 (0.2%)
OTHER 1 (0.2%)

Compare BOSTON SCIENTIFIC - CORK vs BOSTON SCIENTIFIC CORPORATION →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Agents: 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 (477 here).

Enzyme Immunoassay, Digoxin 478 Scaffold, Dissection Repair 478 Nucleic-Acid Tests Used For Infectious Dise… 475 Heart-Valve, Allograft 474

Similar death-typed counts

Nearest other device types by death-typed report count (18 here), distinct from the volume row.

Adaptor 18 Agent, Occluding, Vascular, Permanent 18 Prosthesis 18 Prosthesis 18

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

Disclaimer: MAUDE figures for Agents 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 Agents; 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.