CAREFUSION, INC

FDA MAUDE device safety record · 2015–2026

What the Data Shows About CAREFUSION, INC

CAREFUSION, INC is associated with 6,763 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2015 through 2026. Of the total, 110 are coded as death reports and 1,925 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, INC should be reviewed at the device-family level rather than company-wide. Across those devices, 4 distinct event types appear in the record, led by Malfunction at 4,726 reports (69.9% of total). Patient-outcome categorizations are reported across 13 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 12 years of MAUDE data, with the peak single-year volume reaching 3,182 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.

6,763
Total Reports
110
Death Reports
1,925
Injury Reports
20
Device Types

Event Types

Malfunction 4,726 (69.9%)
Injury 1,925 (28.5%)
Death 110 (1.6%)
2 (0.0%)

Patient Outcomes

3,695 (54.1%)
Other 1,450 (21.2%)
Required Intervention 1,433 (21.0%)
Death 114 (1.7%)
R 55 (0.8%)
Hospitalization 46 (0.7%)
Life Threatening 17 (0.2%)
O 11 (0.2%)
L 7 (0.1%)
D 2 (0.0%)
H 2 (0.0%)
S 2 (0.0%)
Disability 2 (0.0%)

Yearly Trend

15
2015: 27
16
2016: 3,182
17
2017: 1,638
18
2018: 154
19
2019: 212
20
2020: 287
21
2021: 317
22
2022: 174
23
2023: 284
24
2024: 158
25
2025: 285
26
2026: 45

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.