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 386,095 FDA MAUDE reports (#8 of 443, heavy-book tercile). Death-coded event_type share is 1.14% (elevated); Injury share 54.0% (injury-heavy).

What the volume reading shows for BOSTON SCIENTIFIC CORPORATION

The standout signal for BOSTON SCIENTIFIC CORPORATION is filing volume: 386,095 adverse-event reports in FDA MAUDE (#8 of 443, 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 208,500 (54.0% of event_type total). Peak single-year volume reaches 64,121 reports across 32 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

386,095
Total Reports
4,388
Event-type Death
208,500
Injury Reports
20
Device Types

Event Types

Injury 208,500 (54.0%)
Malfunction 173,110 (44.8%)
Death 4,388 (1.1%)
61 (0.0%)
Other 36 (0.0%)

Patient Outcomes

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

175,010 (30.6%)
Hospitalization 111,434 (19.5%)
R 108,231 (18.9%)
Required Intervention 71,247 (12.5%)
H 50,593 (8.9%)
L 21,958 (3.8%)
Other 20,469 (3.6%)
O 5,080 (0.9%)
Death 3,424 (0.6%)
Life Threatening 2,941 (0.5%)
D 419 (0.1%)
S 216 (0.0%)
Disability 126 (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: 513
07
2007: 569
08
2008: 3,960
09
2009: 6,345
10
2010: 221
11
2011: 54
12
2012: 59
13
2013: 176
14
2014: 250
15
2015: 230
16
2016: 328
17
2017: 412
18
2018: 11,400
19
2019: 41,528
20
2020: 42,945
21
2021: 45,377
22
2022: 48,574
23
2023: 50,689
24
2024: 56,324
25
2025: 64,121
26
2026: 11,742