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2026 data FDA MAUDE openFDA FDA Class III

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.

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FDA MAUDE casebook

openFDA event book Device, Hemostasis, Vascular HEAVY-BOOK · MAUDE

#34 of 1000 · 123,919 reports · 1996–2026

  • BOOK 123,919 reports
  • RANK #34 of 1000
  • DEATH 741 death-typed
  • INJ 102,551 injury-typed
  • MALF 20,109 malfunction
  • SPAN 1996–2026
  • PEAK 2024: 13,762
  • PHOTO Coronary Drug-Eluting…

Nearest event-volume peer: Coronary Drug-Eluting Stent (4,796 report gap)

Device, Hemostasis, Vascular sits #34 of 1000 among tracked device types with 123,919 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 →

Injury-coded reports run above the device-type norm

Device, Hemostasis, Vascular carries 82.8% INJURY-coded reports, 52.5pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.6% corpus 1.5% · below corpus mean (-0.9 pp)
  • INJ 82.8% corpus 30.3% · above corpus mean (+52.5 pp)
  • MALF 16.2% corpus 64.8% · below corpus mean (-48.6 pp)

Lead product-problem code Failure to Cycle is 31% of coded problems · Lead manufacturer ABBOTT VASCULAR accounts for 40% 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 123,919 MAUDE reports, ranked #34 of 1000.

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

Event Types

Injury 102,551 (82.8%)
Malfunction 20,109 (16.2%)
Death 741 (0.6%)
Other 397 (0.3%)
121 (0.1%)

Patient Outcomes

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

Required Intervention 94,345 (72.2%)
19,534 (15.0%)
R 5,754 (4.4%)
Hospitalization 5,227 (4.0%)
Other 2,502 (1.9%)
Death 779 (0.6%)
O 704 (0.5%)
Life Threatening 499 (0.4%)
H 497 (0.4%)
L 425 (0.3%)
S 218 (0.2%)
Disability 80 (0.1%)
D 23 (0.0%)
Congenital Anomaly 12 (0.0%)
C 3 (0.0%)

Top Product Problems

Failure to Cycle 35,324
Device Operates Differently Than Expected 16,883
Material Separation 8,524
Improper or Incorrect Procedure or Method 5,724
Positioning Failure 5,624
Difficult to Remove 5,255
Detachment Of Device Component 4,210
Adverse Event Without Identified Device or Use Problem 4,172
Malposition of Device 3,715
Insufficient Device Problem Information 3,678
Unknown (for use when the device problem is not known) 3,261
Difficult to Insert 2,737
Activation, Positioning or Separation Problem 2,108
Difficult to Open or Close 1,990
Entrapment of Device 1,953
Patient Device Interaction Problem 1,876
Off-Label Use 1,867
Break 1,842
Defective Component 1,733
Retraction Problem 1,611

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: 3,933
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: 3,466

Reports in 2025 (12,862) held close to the prior two-year average of 13,646.

Related Entities for Device, Hemostasis, Vascular

Top Manufacturers

ABBOTT VASCULAR 37,819
AV-TEMECULA-CT 28,402
ABBOTT VASCULAR INC. 17,256
TERUMO MEDICAL CORPORATION 8,595
ST. JUDE MEDICAL 2,197

Event Locations

78,618 (63.4%)
I 34,264 (27.7%)
OTHER 6,556 (5.3%)
HOSPITAL 3,780 (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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Device, Hemostasis, Vascular: 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 (123,919 here).

Coronary Drug-Eluting Stent 128,715 Electrosurgical 117,697 Prosthesis 117,618 Sensor 117,148

Similar death-typed counts

Nearest other device types by death-typed report count (741 here), distinct from the volume row.

Stimulator 729 Cardiac Ablation Percutaneous Catheter 724 System 777 Set, Administration, Intravascular 779

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

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.