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 65,152 FDA MAUDE reports (#50 of 443, heavy-book tercile). Death-coded event_type share is 2.00% (elevated); Injury share 76.9% (injury-heavy).

What the volume reading shows for ABBOTT VASCULAR

The standout signal for ABBOTT VASCULAR is filing volume: 65,152 adverse-event reports in FDA MAUDE (#50 of 443, heavy-book). Death-coded event_type share sits at 2.00% (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 50,070 (76.9% 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.

65,152
Total Reports
1,306
Event-type Death
50,070
Injury Reports
20
Device Types

Event Types

Injury 50,070 (76.9%)
Malfunction 13,717 (21.1%)
Death 1,306 (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 43,578 (61.6%)
13,696 (19.3%)
Hospitalization 3,512 (5.0%)
R 3,400 (4.8%)
Other 2,695 (3.8%)
Death 1,301 (1.8%)
S 1,155 (1.6%)
H 728 (1.0%)
O 277 (0.4%)
Disability 221 (0.3%)
L 128 (0.2%)
Life Threatening 84 (0.1%)
D 20 (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: 13,090
23
2023: 14,672
24
2024: 7,112
25
2025: 778
26
2026: 105