BOSTON SCIENTIFIC CORPORATION

Manufacturer adverse-event records for BOSTON SCIENTIFIC CORPORATION 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 · injury-heavy

Volume signature

BOSTON SCIENTIFIC CORPORATION sits in the heavy MAUDE book

BOSTON SCIENTIFIC CORPORATION accounts for 417,411 FDA MAUDE reports (#8 of 434, heavy-book tercile). Death-coded event_type share is 1.14% (elevated); Injury share 53.5% (injury-heavy).

What the volume reading shows for BOSTON SCIENTIFIC CORPORATION

The standout signal for BOSTON SCIENTIFIC CORPORATION is filing volume: 417,411 adverse-event reports in FDA MAUDE (#8 of 434, heavy-book). Death-coded event_type share sits at 1.14% (elevated).

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair BOSTON SCIENTIFIC CORPORATION 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 Injury at 223,455 (53.5% of event_type total). Peak single-year volume reaches 64,131 reports across 32 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

417,411
Total Reports
4,745
Event-type Death
223,455
Injury Reports
20
Device Types

Event Types

Injury 223,455 (53.5%)
Malfunction 189,109 (45.3%)
Death 4,745 (1.1%)
61 (0.0%)
Other 41 (0.0%)

Patient Outcomes

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

188,299 (31.1%)
Hospitalization 115,895 (19.2%)
R 112,488 (18.6%)
Required Intervention 76,487 (12.6%)
H 54,865 (9.1%)
Other 22,147 (3.7%)
L 22,057 (3.6%)
O 5,386 (0.9%)
Death 3,613 (0.6%)
Life Threatening 3,049 (0.5%)
D 484 (0.1%)
S 233 (0.0%)
Disability 140 (0.0%)
Congenital Anomaly 2 (0.0%)
C 1 (0.0%)

Yearly Trend

92
1992: 4
93
1993: 2
94
1994: 2
96
1996: 20
99
1999: 2
00
2000: 7
01
2001: 13
02
2002: 5
03
2003: 26
04
2004: 51
05
2005: 146
06
2006: 514
07
2007: 573
08
2008: 3,961
09
2009: 6,348
10
2010: 221
11
2011: 53
12
2012: 65
13
2013: 176
14
2014: 250
15
2015: 233
16
2016: 328
17
2017: 412
18
2018: 11,404
19
2019: 41,529
20
2020: 42,946
21
2021: 45,376
22
2022: 48,574
23
2023: 50,690
24
2024: 56,326
25
2025: 64,131
26
2026: 43,023