2026 data FDA MAUDE openFDA

Device, Hemostasis, Vascular

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, Hemostasis, Vascular HEAVY-BOOK · MAUDE

#33 of 1000 · 121,291 reports · 1996–2026

  • BOOK 121,291 reports
  • RANK #33 of 1000
  • DEATH 730 death-typed
  • INJ 101,970 injury-typed
  • MALF 18,077 malfunction
  • SPAN 1996–2026
  • PEAK 2024: 13,762
  • PHOTO System

Nearest event-volume peer: System, Surgical, Computer Controlled Instrument (2,837 report gap)

Device, Hemostasis, Vascular sits #33 of 1000 among tracked device types with 121,291 MAUDE reports spanning 1996–2026. 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 0.6% corpus 1.5% · below corpus mean (-0.9 pp)
  • INJ 84.1% corpus 30.4% · above corpus mean (+53.6 pp)
  • MALF 14.9% corpus 64.5% · below corpus mean (-49.6 pp)

Lead product-problem code Failure to Cycle is 42% of coded problems · Lead manufacturer ABBOTT VASCULAR accounts for 41% of manufacturer-tagged reports · Top event location is 63% of location-tagged rows .

Device, Hemostasis, Vascular in the event-volume neighbourhood

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

reports

What this shows Device, Hemostasis, Vascular carries 121,291 MAUDE reports, ranked #33 of 1000.

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

Event Types

Injury 101,970 (84.1%)
Malfunction 18,077 (14.9%)
Death 730 (0.6%)
Other 393 (0.3%)
121 (0.1%)

Patient Outcomes

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

Required Intervention 94,102 (73.1%)
18,203 (14.1%)
R 5,713 (4.4%)
Hospitalization 5,203 (4.0%)
Other 2,398 (1.9%)
Death 770 (0.6%)
O 685 (0.5%)
H 477 (0.4%)
Life Threatening 463 (0.4%)
L 416 (0.3%)
S 217 (0.2%)
Disability 77 (0.1%)
D 23 (0.0%)
Congenital Anomaly 12 (0.0%)
C 3 (0.0%)

Top Product Problems

Failure to Cycle 35,259
Material Separation 8,013
Device Operates Differently Than Expected 5,944
Improper or Incorrect Procedure or Method 3,637
Malposition of Device 3,146
Adverse Event Without Identified Device or Use Problem 2,906
Insufficient Information 2,277
Difficult to Remove 2,190
Positioning Failure 2,133
Activation, Positioning or Separation Problem 1,885
Patient Device Interaction Problem 1,875
Difficult to Open or Close 1,832
Off-Label Use 1,826
Entrapment of Device 1,744
Detachment Of Device Component 1,719
Difficult to Insert 1,704
Defective Component 1,356
Obstruction of Flow 1,335
Mechanical Jam 1,296
Failure to Fire 1,272

Yearly Trend

96
1996: 52
97
1997: 414
98
1998: 672
99
1999: 685
00
2000: 701
01
2001: 745
02
2002: 646
03
2003: 687
04
2004: 593
05
2005: 510
06
2006: 670
07
2007: 1,588
08
2008: 2,267
09
2009: 2,436
10
2010: 3,932
11
2011: 4,011
12
2012: 3,786
13
2013: 3,011
14
2014: 4,468
15
2015: 3,944
16
2016: 4,330
17
2017: 5,346
18
2018: 5,679
19
2019: 6,156
20
2020: 5,927
21
2021: 7,586
22
2022: 9,457
23
2023: 13,529
24
2024: 13,762
25
2025: 12,862
26
2026: 839

Related Entities for Device, Hemostasis, Vascular

Event Locations

76,029 (62.7%)
I 34,266 (28.3%)
OTHER 6,556 (5.4%)
HOSPITAL 3,739 (3.1%)
NO INFORMATION 298 (0.2%)
INVALID DATA 166 (0.1%)
HOME 83 (0.1%)
UNKNOWN 77 (0.1%)
NOT APPLICABLE 38 (0.0%)
OUTPATIENT TREATMENT FACILITY 27 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 5 (0.0%)
OPERATING ROOM 4 (0.0%)
AMBULATORY SURGICAL FACILITY 2 (0.0%)
CATHETERIZATION LAB - FREE STANDING 1 (0.0%)

Compare ABBOTT VASCULAR vs AV-TEMECULA-CT →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Device, Hemostasis, Vascular, 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 (121,291 here).

Similar death-typed counts

Nearest other device types by death-typed report count (730 here), distinct from the volume row.

Disclaimer: MAUDE figures for Device, Hemostasis, Vascular 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, Hemostasis, Vascular; 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.