CAREFUSION CORPORATION

FDA MAUDE device safety record · 2009–2025

What the Data Shows About CAREFUSION CORPORATION

CAREFUSION CORPORATION is associated with 3,844 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2009 through 2025. Of the total, 52 are coded as death reports and 596 as injury reports, with the remainder classified as malfunctions or other event types. These counts reflect reports submitted to the FDA by manufacturers, healthcare facilities, and patients — they are raw signal, not adjudicated safety findings, and higher-volume manufacturers or older product portfolios naturally generate larger raw counts.

The reports span 20 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for CAREFUSION CORPORATION should be reviewed at the device-family level rather than company-wide. Across those devices, 5 distinct event types appear in the record, led by Malfunction at 3,176 reports (82.6% of total). Patient-outcome categorizations are reported across 11 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 15 years of MAUDE data, with the peak single-year volume reaching 955 reports — trend shape can reflect shifts in device sales, FDA reporting requirements, or post-market recall activity as much as intrinsic device performance. The MAUDE system is one input among many in FDA post-market surveillance and does not draw safety conclusions from individual submissions. All figures reflect the openFDA snapshot refreshed on , and nothing on this page is medical or regulatory advice — consult a qualified clinician or the FDA for current safety communications.

3,844
Total Reports
52
Death Reports
596
Injury Reports
20
Device Types

Event Types

Malfunction 3,176 (82.6%)
Injury 596 (15.5%)
Death 52 (1.4%)
Other 18 (0.5%)
2 (0.1%)

Patient Outcomes

3,171 (81.6%)
Required Intervention 386 (9.9%)
Other 202 (5.2%)
Death 51 (1.3%)
R 32 (0.8%)
Life Threatening 20 (0.5%)
Hospitalization 12 (0.3%)
O 6 (0.2%)
L 2 (0.1%)
Disability 2 (0.1%)
H 1 (0.0%)

Yearly Trend

09
2009: 104
10
2010: 237
11
2011: 754
12
2012: 714
13
2013: 852
14
2014: 955
15
2015: 194
16
2016: 2
17
2017: 13
18
2018: 3
19
2019: 8
20
2020: 4
21
2021: 2
24
2024: 1
25
2025: 1

Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a manufacturer's products are unsafe — higher-volume manufacturers naturally generate more reports.