2026 data FDA MAUDE openFDA

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 MAUDE casebook

openFDA event book Device, Neurovascular Embolization MID-BOOK · MAUDE

#113 of 1000 · 25,981 reports · 1995–2026

  • BOOK 25,981 reports
  • RANK #113 of 1000
  • DEATH 640 death-typed
  • INJ 6,238 injury-typed
  • MALF 18,954 malfunction
  • SPAN 1995–2026
  • PEAK 2017: 2,494
  • PHOTO Stapler, Surgical

Nearest event-volume peer: Stapler, Surgical (45 report gap)

Device, Neurovascular Embolization sits #113 of 1000 among tracked device types with 25,981 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 →

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 2.5% corpus 1.5% · above corpus mean (+0.9 pp)
  • INJ 24.0% corpus 30.4% · below corpus mean (-6.4 pp)
  • MALF 73.0% corpus 64.5% · above corpus mean (+8.4 pp)

Lead product-problem code Failure to Advance is 20% 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

reports

What this shows Device, Neurovascular Embolization carries 25,981 MAUDE reports, ranked #113 of 1000.

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

Event Types

Malfunction 18,954 (73.0%)
Injury 6,238 (24.0%)
Death 640 (2.5%)
97 (0.4%)
Other 52 (0.2%)

Patient Outcomes

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

18,710 (67.1%)
Required Intervention 3,703 (13.3%)
Other 1,372 (4.9%)
R 1,016 (3.6%)
Death 645 (2.3%)
Hospitalization 608 (2.2%)
Life Threatening 465 (1.7%)
Disability 392 (1.4%)
S 346 (1.2%)
O 268 (1.0%)
L 235 (0.8%)
H 90 (0.3%)
D 13 (0.0%)
Congenital Anomaly 4 (0.0%)
C 1 (0.0%)

Top Product Problems

Failure to Advance 3,718
Physical Resistance/Sticking 2,605
Premature Separation 2,339
Physical Resistance 1,538
Adverse Event Without Identified Device or Use Problem 1,029
Detachment Of Device Component 976
Separation Failure 780
Material Deformation 692
Break 635
Stretched 578
Detachment of Device or Device Component 530
Mechanical Problem 506
Fracture 418
Kinked 382
Premature Activation 355
Difficult or Delayed Separation 349
Migration 311
Mechanical Jam 310
Device Handling Problem 285
Positioning Failure 276

Yearly Trend

95
1995: 2
96
1996: 3
97
1997: 70
98
1998: 98
99
1999: 67
00
2000: 56
01
2001: 85
02
2002: 253
03
2003: 208
04
2004: 285
05
2005: 336
06
2006: 585
07
2007: 326
08
2008: 730
09
2009: 821
10
2010: 851
11
2011: 894
12
2012: 1,146
13
2013: 1,103
14
2014: 1,729
15
2015: 1,598
16
2016: 1,991
17
2017: 2,494
18
2018: 2,058
19
2019: 1,763
20
2020: 1,754
21
2021: 2,268
22
2022: 663
23
2023: 568
24
2024: 552
25
2025: 545
26
2026: 79

Related Entities for Device, Neurovascular Embolization

Event Locations

12,727 (49.0%)
I 12,660 (48.7%)
HOSPITAL 430 (1.7%)
NO INFORMATION 66 (0.3%)
OTHER 39 (0.2%)
INVALID DATA 25 (0.1%)
NOT APPLICABLE 17 (0.1%)
UNKNOWN 13 (0.1%)
HOME 1 (0.0%)
OPERATING ROOM 1 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)

Compare PENUMBRA, INC. vs STRYKER NEUROVASCULAR CORK →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Device, Neurovascular 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 (25,981 here).

Similar death-typed counts

Nearest other device types by death-typed report count (640 here), distinct from the volume row.

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.