BAXTER HEALTHCARE

FDA MAUDE device safety record · 1992–2025

What the Data Shows About BAXTER HEALTHCARE

BAXTER HEALTHCARE is associated with 22,232 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 1992 through 2025. Of the total, 447 are coded as death reports and 7,224 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 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 14,457 reports (65.0% of total). Patient-outcome categorizations are reported across 14 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 32 years of MAUDE data, with the peak single-year volume reaching 6,832 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.

22,232
Total Reports
447
Death Reports
7,224
Injury Reports
20
Device Types

Event Types

Malfunction 14,457 (65.0%)
Injury 7,224 (32.5%)
Death 447 (2.0%)
55 (0.2%)
Other 49 (0.2%)

Patient Outcomes

14,481 (56.6%)
Hospitalization 3,832 (15.0%)
R 3,077 (12.0%)
Required Intervention 2,294 (9.0%)
Other 1,124 (4.4%)
Death 460 (1.8%)
H 173 (0.7%)
O 58 (0.2%)
Life Threatening 31 (0.1%)
L 16 (0.1%)
S 6 (0.0%)
Disability 5 (0.0%)
Congenital Anomaly 3 (0.0%)
Invalid Data 3 (0.0%)

Yearly Trend

92
1992: 2
93
1993: 24
94
1994: 18
95
1995: 34
96
1996: 21
97
1997: 20
98
1998: 18
99
1999: 16
00
2000: 18
01
2001: 38
02
2002: 26
03
2003: 53
04
2004: 79
05
2005: 356
06
2006: 337
07
2007: 122
08
2008: 1,774
09
2009: 295
10
2010: 286
11
2011: 2,500
12
2012: 4,507
13
2013: 6,832
14
2014: 3,740
15
2015: 578
16
2016: 487
17
2017: 25
18
2018: 11
19
2019: 1
20
2020: 8
21
2021: 1
22
2022: 3
25
2025: 2

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.