ABBOTT VASCULAR INC.

Manufacturer adverse-event records for ABBOTT VASCULAR INC. 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 · 2005–2026 · heavy-book · elevated Death-code · injury-heavy

Injury-mix signature

ABBOTT VASCULAR INC. leans injury-heavy in event_type mix

Injury-coded event_type share is 72.6% (injury-heavy tercile) beside 0.76% Death-coded (elevated). Volume band: heavy.

What the Injury-mix reading shows for ABBOTT VASCULAR INC.

The standout signal for ABBOTT VASCULAR INC. is Injury-mix: 72.6% Injury-coded (injury-heavy) beside 0.76% Death-coded, on a heavy-book footprint.

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair ABBOTT VASCULAR INC. 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 17,881 (72.6% of event_type total). Peak single-year volume reaches 12,030 reports across 22 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

24,622
Total Reports
187
Event-type Death
17,881
Injury Reports
20
Device Types

Event Types

Injury 17,881 (72.6%)
Malfunction 6,472 (26.3%)
Death 187 (0.8%)
Other 76 (0.3%)
6 (0.0%)

Patient Outcomes

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

Required Intervention 16,668 (65.7%)
6,232 (24.6%)
Other 754 (3.0%)
R 506 (2.0%)
Hospitalization 419 (1.7%)
H 303 (1.2%)
Death 179 (0.7%)
O 111 (0.4%)
S 70 (0.3%)
Disability 59 (0.2%)
L 41 (0.2%)
Life Threatening 31 (0.1%)
D 10 (0.0%)

Yearly Trend

05
2005: 1
06
2006: 311
07
2007: 738
08
2008: 46
09
2009: 23
10
2010: 4
11
2011: 5
12
2012: 1
13
2013: 3
14
2014: 6
15
2015: 7
16
2016: 6
17
2017: 34
18
2018: 31
19
2019: 14
20
2020: 52
21
2021: 54
22
2022: 56
23
2023: 104
24
2024: 8,424
25
2025: 12,030
26
2026: 2,672