HOSPIRA, INC.

FDA MAUDE device safety record · 2004–2025

What the Data Shows About HOSPIRA, INC.

HOSPIRA, INC. is associated with 4,835 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2004 through 2025. Of the total, 59 are coded as death reports and 418 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 HOSPIRA, INC. 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 4,185 reports (86.6% of total). Patient-outcome categorizations are reported across 12 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 22 years of MAUDE data, with the peak single-year volume reaching 1,044 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.

4,835
Total Reports
59
Death Reports
418
Injury Reports
20
Device Types

Event Types

Malfunction 4,185 (86.6%)
Injury 418 (8.6%)
Other 152 (3.1%)
Death 59 (1.2%)
21 (0.4%)

Patient Outcomes

2,741 (52.6%)
Other 1,584 (30.4%)
R 340 (6.5%)
Life Threatening 319 (6.1%)
Required Intervention 90 (1.7%)
Death 62 (1.2%)
Hospitalization 37 (0.7%)
L 18 (0.3%)
Disability 9 (0.2%)
O 5 (0.1%)
S 4 (0.1%)
H 1 (0.0%)

Yearly Trend

04
2004: 578
05
2005: 724
06
2006: 543
07
2007: 401
08
2008: 438
09
2009: 481
10
2010: 1,044
11
2011: 166
12
2012: 172
13
2013: 68
14
2014: 34
15
2015: 24
16
2016: 10
17
2017: 20
18
2018: 12
19
2019: 21
20
2020: 17
21
2021: 6
22
2022: 5
23
2023: 6
24
2024: 8
25
2025: 57

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.