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 · typical Death-code · injury-heavy

Injury-mix signature

ABBOTT VASCULAR INC. leans injury-heavy in event_type mix

Injury-coded event_type share is 75.6% (injury-heavy tercile) beside 0.68% Death-coded (typical). Volume band: heavy.

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

The standout signal for ABBOTT VASCULAR INC. is Injury-mix: 75.6% Injury-coded (injury-heavy) beside 0.68% 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 17,222 (75.6% of event_type total). Peak single-year volume reaches 12,057 reports across 22 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

22,768
Total Reports
154
Event-type Death
17,222
Injury Reports
20
Device Types

Event Types

Injury 17,222 (75.6%)
Malfunction 5,310 (23.3%)
Death 154 (0.7%)
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 16,214 (68.6%)
5,218 (22.1%)
Other 668 (2.8%)
R 454 (1.9%)
Hospitalization 361 (1.5%)
H 256 (1.1%)
Death 153 (0.6%)
O 109 (0.5%)
S 56 (0.2%)
Disability 53 (0.2%)
L 40 (0.2%)
Life Threatening 30 (0.1%)
D 8 (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: 55
23
2023: 104
24
2024: 8,425
25
2025: 12,057
26
2026: 791