CAREFUSION

Manufacturer adverse-event records for CAREFUSION 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 · 2009–2025 · heavy-book · elevated Death-code · balanced

Volume signature

CAREFUSION sits in the heavy MAUDE book

CAREFUSION accounts for 28,364 FDA MAUDE reports (#114 of 443, heavy-book tercile). Death-coded event_type share is 0.90% (elevated); Injury share 11.3% (balanced).

What the volume reading shows for CAREFUSION

The standout signal for CAREFUSION is filing volume: 28,364 adverse-event reports in FDA MAUDE (#114 of 443, 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 CAREFUSION 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 24,631 (86.8% of event_type total). Peak single-year volume reaches 6,181 reports across 17 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

28,364
Total Reports
256
Event-type Death
3,208
Injury Reports
20
Device Types

Event Types

Malfunction 24,631 (86.8%)
Injury 3,208 (11.3%)
Death 256 (0.9%)
205 (0.7%)
Other 64 (0.2%)

Patient Outcomes

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

23,571 (82.3%)
Required Intervention 2,184 (7.6%)
Other 2,161 (7.5%)
Death 257 (0.9%)
R 244 (0.9%)
Life Threatening 95 (0.3%)
Hospitalization 69 (0.2%)
Disability 20 (0.1%)
L 13 (0.0%)
O 12 (0.0%)
S 7 (0.0%)
Congenital Anomaly 7 (0.0%)
H 1 (0.0%)

Yearly Trend

09
2009: 97
10
2010: 310
11
2011: 563
12
2012: 569
13
2013: 464
14
2014: 644
15
2015: 4,833
16
2016: 3,580
17
2017: 2,428
18
2018: 3,450
19
2019: 5,222
20
2020: 6,181
21
2021: 6
22
2022: 3
23
2023: 6
24
2024: 3
25
2025: 5