BOSTON SCIENTIFIC - GALWAY

Manufacturer adverse-event records for BOSTON SCIENTIFIC - GALWAY 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 · 2006–2018 · heavy-book · elevated Death-code · balanced

Death-code intensity

BOSTON SCIENTIFIC - GALWAY carries an elevated Death-code share

Death-coded event_type rows are 1,891 of 37,538 (5.04% · elevated tercile among 443 manufacturers). Absolute volume is heavy-book.

What the Death-code reading shows for BOSTON SCIENTIFIC - GALWAY

The standout signal for BOSTON SCIENTIFIC - GALWAY is Death-code intensity: 5.04% of 37,538 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 - GALWAY 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 22,975 (61.2% of event_type total). Peak single-year volume reaches 6,138 reports across 11 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

37,538
Total Reports
1,891
Event-type Death
12,652
Injury Reports
20
Device Types

Event Types

Malfunction 22,975 (61.2%)
Injury 12,652 (33.7%)
Death 1,891 (5.0%)
20 (0.1%)

Patient Outcomes

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

23,090 (58.5%)
Required Intervention 8,819 (22.3%)
Other 2,003 (5.1%)
Death 1,900 (4.8%)
R 1,812 (4.6%)
Hospitalization 1,713 (4.3%)
H 65 (0.2%)
O 50 (0.1%)
Life Threatening 13 (0.0%)
L 5 (0.0%)
D 1 (0.0%)
S 1 (0.0%)

Yearly Trend

06
2006: 3
09
2009: 18
10
2010: 2,844
11
2011: 2,535
12
2012: 3,830
13
2013: 4,339
14
2014: 3,657
15
2015: 4,329
16
2016: 6,138
17
2017: 6,106
18
2018: 3,739