ABBOTT LABORATORIES

Manufacturer adverse-event records for ABBOTT LABORATORIES 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 · 1992–2026 · mid-book · elevated Death-code · injury-light

Injury-mix signature

ABBOTT LABORATORIES is lighter on Injury codes

Injury-coded event_type share is 6.6% (injury-light tercile) beside 0.87% Death-coded (elevated). Volume band: mid.

What the Injury-mix reading shows for ABBOTT LABORATORIES

The standout signal for ABBOTT LABORATORIES is Injury-mix: 6.6% Injury-coded (injury-light) beside 0.87% Death-coded, on a mid-book footprint.

Mid-pack volume still shows a clear device fingerprint; the table below is the actionable layer for ABBOTT LABORATORIES. Event_type Death/Injury codes differ from patient-outcome rows - see methodology.

Reports span 20 device types, led in this extract by Malfunction at 16,295 (87.5% of event_type total). Peak single-year volume reaches 2,139 reports across 35 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

18,623
Total Reports
162
Event-type Death
1,232
Injury Reports
20
Device Types

Event Types

Malfunction 16,295 (87.5%)
Injury 1,232 (6.6%)
Other 778 (4.2%)
Death 162 (0.9%)
156 (0.8%)

Patient Outcomes

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

11,663 (61.5%)
Other 5,415 (28.6%)
Required Intervention 632 (3.3%)
R 344 (1.8%)
Life Threatening 314 (1.7%)
Death 169 (0.9%)
Disability 159 (0.8%)
Hospitalization 143 (0.8%)
L 43 (0.2%)
O 26 (0.1%)
S 22 (0.1%)
Invalid Data 19 (0.1%)
H 5 (0.0%)
Not Applicable 2 (0.0%)

Yearly Trend

92
1992: 16
93
1993: 30
94
1994: 150
95
1995: 103
96
1996: 272
97
1997: 609
98
1998: 585
99
1999: 576
00
2000: 751
01
2001: 995
02
2002: 1,052
03
2003: 1,409
04
2004: 476
05
2005: 76
06
2006: 110
07
2007: 327
08
2008: 525
09
2009: 1,271
10
2010: 604
11
2011: 466
12
2012: 2,139
13
2013: 441
14
2014: 252
15
2015: 59
16
2016: 138
17
2017: 221
18
2018: 189
19
2019: 245
20
2020: 318
21
2021: 660
22
2022: 785
23
2023: 839
24
2024: 907
25
2025: 905
26
2026: 122