SMITHS MEDICAL ASD, INC.

Manufacturer adverse-event records for SMITHS MEDICAL ASD, INC. come from the U.S. Food & Drug Administration (FDA) MAUDE database via openFDA, refreshed March 2026 - see our methodology. Not medical advice.

FDA MAUDE device safety record · 2003–2026 · heavy-book · typical Death-code · injury-light

Volume signature

SMITHS MEDICAL ASD, INC. sits in the heavy MAUDE book

SMITHS MEDICAL ASD, INC. accounts for 50,715 FDA MAUDE reports (#72 of 443, heavy-book tercile). Death-coded event_type share is 0.27% (typical); Injury share 8.2% (injury-light).

What the volume reading shows for SMITHS MEDICAL ASD, INC.

The standout signal for SMITHS MEDICAL ASD, INC. is filing volume: 50,715 adverse-event reports in FDA MAUDE (#72 of 443, heavy-book). Death-coded event_type share sits at 0.27% (typical).

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair SMITHS MEDICAL ASD, INC. with device-family pages before treating company totals as a safety verdict. Event_type Death and Injury are one code per report; Patient Outcomes below use a separate FDA population.

Reports span 20 device types, led in this extract by Malfunction at 46,355 (91.4% of event_type total). Peak single-year volume reaches 13,547 reports across 24 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

50,715
Total Reports
136
Event-type Death
4,146
Injury Reports
20
Device Types

Event Types

Malfunction 46,355 (91.4%)
Injury 4,146 (8.2%)
Death 136 (0.3%)
58 (0.1%)
Other 20 (0.0%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

46,373 (90.1%)
Required Intervention 2,549 (5.0%)
Other 701 (1.4%)
Hospitalization 584 (1.1%)
R 453 (0.9%)
Life Threatening 240 (0.5%)
O 201 (0.4%)
Death 140 (0.3%)
L 125 (0.2%)
S 36 (0.1%)
Disability 24 (0.0%)
Congenital Anomaly 15 (0.0%)
H 11 (0.0%)
D 4 (0.0%)

Yearly Trend

03
2003: 4
04
2004: 121
05
2005: 74
06
2006: 75
07
2007: 84
08
2008: 98
09
2009: 168
10
2010: 256
11
2011: 433
12
2012: 264
13
2013: 273
14
2014: 172
15
2015: 235
16
2016: 817
17
2017: 2,117
18
2018: 4,488
19
2019: 5,416
20
2020: 4,642
21
2021: 3,702
22
2022: 6,413
23
2023: 3,050
24
2024: 13,547
25
2025: 4,255
26
2026: 11