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 53,632 FDA MAUDE reports (#66 of 443, heavy-book tercile). Death-coded event_type share is 1.14% (elevated); Injury share 18.6% (balanced).

What the volume reading shows for COVIDIEN

The standout signal for COVIDIEN is filing volume: 53,632 adverse-event reports in FDA MAUDE (#66 of 443, heavy-book). Death-coded event_type share sits at 1.14% (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 42,247 (78.8% 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.

53,632
Total Reports
612
Event-type Death
9,986
Injury Reports
20
Device Types

Event Types

Malfunction 42,247 (78.8%)
Injury 9,986 (18.6%)
Other 623 (1.2%)
Death 612 (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.

41,927 (76.9%)
Required Intervention 7,511 (13.8%)
Other 2,583 (4.7%)
Death 601 (1.1%)
Hospitalization 583 (1.1%)
R 539 (1.0%)
O 171 (0.3%)
Disability 166 (0.3%)
Life Threatening 155 (0.3%)
H 121 (0.2%)
S 94 (0.2%)
L 77 (0.1%)
Congenital Anomaly 10 (0.0%)
D 9 (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: 1,178
25
2025: 4,704
26
2026: 1,072