COVIDIEN

Manufacturer adverse-event records for COVIDIEN 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 · 2006–2026 · heavy-book · elevated Death-code · balanced

Volume signature

COVIDIEN sits in the heavy MAUDE book

COVIDIEN accounts for 56,472 FDA MAUDE reports (#66 of 434, heavy-book tercile). Death-coded event_type share is 1.12% (elevated); Injury share 18.3% (balanced).

What the volume reading shows for COVIDIEN

The standout signal for COVIDIEN is filing volume: 56,472 adverse-event reports in FDA MAUDE (#66 of 434, heavy-book). Death-coded event_type share sits at 1.12% (elevated).

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair COVIDIEN 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 44,727 (79.2% of event_type total). Peak single-year volume reaches 9,734 reports across 21 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

56,472
Total Reports
631
Event-type Death
10,327
Injury Reports
20
Device Types

Event Types

Malfunction 44,727 (79.2%)
Injury 10,327 (18.3%)
Death 631 (1.1%)
Other 623 (1.1%)
163 (0.3%)
No answer provided 1 (0.0%)

Patient Outcomes

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

43,924 (77.1%)
Required Intervention 7,701 (13.5%)
Other 2,669 (4.7%)
Hospitalization 622 (1.1%)
Death 614 (1.1%)
R 577 (1.0%)
O 199 (0.3%)
Disability 167 (0.3%)
Life Threatening 165 (0.3%)
H 163 (0.3%)
S 95 (0.2%)
L 90 (0.2%)
D 11 (0.0%)
Congenital Anomaly 10 (0.0%)

Yearly Trend

06
2006: 1
07
2007: 13
08
2008: 259
09
2009: 1,017
10
2010: 1,081
11
2011: 975
12
2012: 1,237
13
2013: 2,096
14
2014: 3,860
15
2015: 5,205
16
2016: 9,734
17
2017: 7,896
18
2018: 3,553
19
2019: 2,541
20
2020: 2,734
21
2021: 2,214
22
2022: 906
23
2023: 1,356
24
2024: 1,179
25
2025: 4,718
26
2026: 3,897