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 68,532 FDA MAUDE reports (#48 of 443, heavy-book tercile). Death-coded event_type share is 2.33% (elevated); Injury share 79.1% (injury-heavy).

What the volume reading shows for ABBOTT MEDICAL

The standout signal for ABBOTT MEDICAL is filing volume: 68,532 adverse-event reports in FDA MAUDE (#48 of 443, heavy-book). Death-coded event_type share sits at 2.33% (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 54,205 (79.1% of event_type total). Peak single-year volume reaches 16,903 reports across 14 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

68,532
Total Reports
1,596
Event-type Death
54,205
Injury Reports
20
Device Types

Event Types

Injury 54,205 (79.1%)
Malfunction 12,719 (18.6%)
Death 1,596 (2.3%)
Other 12 (0.0%)

Patient Outcomes

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

Other 40,955 (53.8%)
12,634 (16.6%)
Required Intervention 9,730 (12.8%)
R 2,946 (3.9%)
Hospitalization 2,589 (3.4%)
H 2,539 (3.3%)
Death 1,443 (1.9%)
O 1,116 (1.5%)
L 643 (0.8%)
S 486 (0.6%)
Life Threatening 473 (0.6%)
Disability 297 (0.4%)
D 234 (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: 16,903
26
2026: 2,880