ABBOTT VASCULAR

Manufacturer adverse-event records for ABBOTT VASCULAR come from the U.S. Food & Drug Administration (FDA) MAUDE database via openFDA, refreshed March 2026 - see our methodology. Not medical advice.

FDA MAUDE device safety record · 2002–2026 · heavy-book · elevated Death-code · injury-heavy

Volume signature

ABBOTT VASCULAR sits in the heavy MAUDE book

ABBOTT VASCULAR accounts for 65,414 FDA MAUDE reports (#54 of 434, heavy-book tercile). Death-coded event_type share is 2.02% (elevated); Injury share 76.7% (injury-heavy).

What the volume reading shows for ABBOTT VASCULAR

The standout signal for ABBOTT VASCULAR is filing volume: 65,414 adverse-event reports in FDA MAUDE (#54 of 434, heavy-book). Death-coded event_type share sits at 2.02% (elevated).

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair ABBOTT VASCULAR with device-family pages before treating company totals as a safety verdict. Event_type Death and Injury are one code per report; Patient Outcomes below use a separate FDA population.

Reports span 20 device types, led in this extract by Injury at 50,183 (76.7% of event_type total). Peak single-year volume reaches 14,672 reports across 25 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

65,414
Total Reports
1,320
Event-type Death
50,183
Injury Reports
20
Device Types

Event Types

Injury 50,183 (76.7%)
Malfunction 13,852 (21.2%)
Death 1,320 (2.0%)
40 (0.1%)
Other 19 (0.0%)

Patient Outcomes

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

Required Intervention 43,639 (61.4%)
13,804 (19.4%)
Hospitalization 3,528 (5.0%)
R 3,419 (4.8%)
Other 2,725 (3.8%)
Death 1,317 (1.9%)
S 1,161 (1.6%)
H 739 (1.0%)
O 278 (0.4%)
Disability 228 (0.3%)
L 129 (0.2%)
Life Threatening 84 (0.1%)
D 19 (0.0%)

Yearly Trend

02
2002: 8
03
2003: 14
04
2004: 5
05
2005: 8
06
2006: 5
07
2007: 30
08
2008: 101
09
2009: 95
10
2010: 60
11
2011: 49
12
2012: 57
13
2013: 60
14
2014: 53
15
2015: 45
16
2016: 71
17
2017: 75
18
2018: 47
19
2019: 5,188
20
2020: 11,131
21
2021: 12,293
22
2022: 13,089
23
2023: 14,672
24
2024: 7,113
25
2025: 779
26
2026: 366