BAXTER HEALTHCARE CORPORATION

FDA MAUDE device safety record · 1992–2026

What the Data Shows About BAXTER HEALTHCARE CORPORATION

BAXTER HEALTHCARE CORPORATION is associated with 175,331 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 1992 through 2026. Of the total, 2,331 are coded as death reports and 32,946 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 BAXTER HEALTHCARE CORPORATION should be reviewed at the device-family level rather than company-wide. Across those devices, 6 distinct event types appear in the record, led by Malfunction at 139,666 reports (79.7% of total). Patient-outcome categorizations are reported across 16 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 35 years of MAUDE data, with the peak single-year volume reaching 33,475 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.

175,331
Total Reports
2,331
Death Reports
32,946
Injury Reports
20
Device Types

Event Types

Malfunction 139,666 (79.7%)
Injury 32,946 (18.8%)
Death 2,331 (1.3%)
Other 204 (0.1%)
182 (0.1%)
No answer provided 2 (0.0%)

Patient Outcomes

138,919 (73.7%)
Hospitalization 15,169 (8.1%)
Required Intervention 11,329 (6.0%)
R 11,106 (5.9%)
Other 6,923 (3.7%)
Death 2,347 (1.2%)
H 1,760 (0.9%)
O 399 (0.2%)
Life Threatening 212 (0.1%)
D 95 (0.1%)
Congenital Anomaly 42 (0.0%)
L 37 (0.0%)
S 19 (0.0%)
Disability 16 (0.0%)
Invalid Data 4 (0.0%)
C 1 (0.0%)

Yearly Trend

92
1992: 27
93
1993: 17
94
1994: 18
95
1995: 4
96
1996: 35
97
1997: 93
98
1998: 120
99
1999: 114
00
2000: 319
01
2001: 526
02
2002: 602
03
2003: 169
04
2004: 980
05
2005: 1,611
06
2006: 1,215
07
2007: 276
08
2008: 614
09
2009: 44
10
2010: 20
11
2011: 543
12
2012: 365
13
2013: 12,801
14
2014: 33,475
15
2015: 16,947
16
2016: 11,866
17
2017: 3,843
18
2018: 2,870
19
2019: 4,123
20
2020: 14,089
21
2021: 14,140
22
2022: 14,617
23
2023: 13,148
24
2024: 10,268
25
2025: 13,550
26
2026: 1,882

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.