ABBOTT
Manufacturer adverse-event records for ABBOTT 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 · heavy-book · elevated Death-code · balanced
Volume signature
ABBOTT sits in the heavy MAUDE book
ABBOTT accounts for 39,282 FDA MAUDE reports (#94 of 434, heavy-book tercile). Death-coded event_type share is 0.90% (elevated); Injury share 40.8% (balanced).
What the volume reading shows for ABBOTT
The standout signal for ABBOTT is filing volume: 39,282 adverse-event reports in FDA MAUDE (#94 of 434, heavy-book). Death-coded event_type share sits at 0.90% (elevated).
As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair ABBOTT 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 Malfunction at 22,837 (58.1% of event_type total). Peak single-year volume reaches 7,098 reports across 35 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Devices (20)
Yearly Trend
Read our methodology - how this data is sourced, computed, and verified.