BOSTON SCIENTIFIC

Manufacturer adverse-event records for BOSTON SCIENTIFIC 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 · 1992–2026 · heavy-book · elevated Death-code · balanced

Death-code intensity

BOSTON SCIENTIFIC carries an elevated Death-code share

Death-coded event_type rows are 1,654 of 29,678 (5.57% · elevated tercile among 443 manufacturers). Absolute volume is heavy-book.

What the Death-code reading shows for BOSTON SCIENTIFIC

The standout signal for BOSTON SCIENTIFIC is Death-code intensity: 5.57% of 29,678 reports (elevated tercile), while absolute volume is heavy-book.

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair BOSTON SCIENTIFIC 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 16,889 (56.9% of event_type total). Peak single-year volume reaches 5,148 reports across 35 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

29,678
Total Reports
1,654
Event-type Death
10,817
Injury Reports
20
Device Types

Event Types

Malfunction 16,889 (56.9%)
Injury 10,817 (36.4%)
Death 1,654 (5.6%)
164 (0.6%)
Other 154 (0.5%)

Patient Outcomes

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

16,870 (51.5%)
Required Intervention 5,955 (18.2%)
Other 3,301 (10.1%)
R 2,111 (6.4%)
Death 1,622 (5.0%)
Hospitalization 1,607 (4.9%)
O 372 (1.1%)
L 356 (1.1%)
Life Threatening 206 (0.6%)
Disability 127 (0.4%)
S 112 (0.3%)
H 90 (0.3%)
D 3 (0.0%)
Congenital Anomaly 3 (0.0%)
Invalid Data 1 (0.0%)

Yearly Trend

92
1992: 2
93
1993: 1
94
1994: 2
95
1995: 1
96
1996: 2
97
1997: 7
98
1998: 7
99
1999: 26
00
2000: 29
01
2001: 24
02
2002: 84
03
2003: 1,121
04
2004: 3,412
05
2005: 4,069
06
2006: 4,719
07
2007: 3,830
08
2008: 4,243
09
2009: 5,148
10
2010: 520
11
2011: 233
12
2012: 197
13
2013: 166
14
2014: 157
15
2015: 220
16
2016: 202
17
2017: 208
18
2018: 196
19
2019: 21
20
2020: 18
21
2021: 8
22
2022: 11
23
2023: 727
24
2024: 43
25
2025: 22
26
2026: 2