ABBOTT MEDICAL

Manufacturer adverse-event records for ABBOTT MEDICAL 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 MEDICAL sits in the heavy MAUDE book

ABBOTT MEDICAL accounts for 77,025 FDA MAUDE reports (#47 of 434, heavy-book tercile). Death-coded event_type share is 2.38% (elevated); Injury share 77.1% (injury-heavy).

What the volume reading shows for ABBOTT MEDICAL

The standout signal for ABBOTT MEDICAL is filing volume: 77,025 adverse-event reports in FDA MAUDE (#47 of 434, heavy-book). Death-coded event_type share sits at 2.38% (elevated).

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair ABBOTT MEDICAL 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 59,415 (77.1% of event_type total). Peak single-year volume reaches 16,931 reports across 14 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

77,025
Total Reports
1,831
Event-type Death
59,415
Injury Reports
20
Device Types

Event Types

Injury 59,415 (77.1%)
Malfunction 15,767 (20.5%)
Death 1,831 (2.4%)
Other 12 (0.0%)

Patient Outcomes

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

Other 43,714 (51.5%)
15,557 (18.3%)
Required Intervention 11,184 (13.2%)
R 3,334 (3.9%)
Hospitalization 2,895 (3.4%)
H 2,853 (3.4%)
Death 1,616 (1.9%)
O 1,317 (1.6%)
L 729 (0.9%)
S 565 (0.7%)
Life Threatening 557 (0.7%)
Disability 334 (0.4%)
D 281 (0.3%)
Congenital Anomaly 1 (0.0%)

Yearly Trend

02
2002: 1
09
2009: 1
13
2013: 2
15
2015: 7
16
2016: 2
18
2018: 4
19
2019: 9
20
2020: 3,277
21
2021: 9,600
22
2022: 9,989
23
2023: 12,178
24
2024: 13,679
25
2025: 16,931
26
2026: 11,345