BOSTON SCIENTIFIC - MARLBOROUGH

Manufacturer adverse-event records for BOSTON SCIENTIFIC - MARLBOROUGH 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 · 2008–2018 · heavy-book · typical Death-code · injury-heavy

Injury-mix signature

BOSTON SCIENTIFIC - MARLBOROUGH leans injury-heavy in event_type mix

Injury-coded event_type share is 73.9% (injury-heavy tercile) beside 0.17% Death-coded (typical). Volume band: heavy.

What the Injury-mix reading shows for BOSTON SCIENTIFIC - MARLBOROUGH

The standout signal for BOSTON SCIENTIFIC - MARLBOROUGH is Injury-mix: 73.9% Injury-coded (injury-heavy) beside 0.17% Death-coded, on a heavy-book footprint.

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair BOSTON SCIENTIFIC - MARLBOROUGH 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 18,901 (73.9% of event_type total). Peak single-year volume reaches 12,548 reports across 11 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

25,574
Total Reports
43
Event-type Death
18,901
Injury Reports
20
Device Types

Event Types

Injury 18,901 (73.9%)
Malfunction 6,627 (25.9%)
Death 43 (0.2%)
3 (0.0%)

Patient Outcomes

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

Other 16,104 (62.2%)
6,712 (25.9%)
Required Intervention 2,509 (9.7%)
R 272 (1.1%)
Hospitalization 203 (0.8%)
Death 46 (0.2%)
O 33 (0.1%)
H 6 (0.0%)
L 1 (0.0%)
S 1 (0.0%)

Yearly Trend

08
2008: 2
09
2009: 35
10
2010: 1,437
11
2011: 1,330
12
2012: 3,537
13
2013: 12,548
14
2014: 1,784
15
2015: 1,116
16
2016: 1,394
17
2017: 1,488
18
2018: 903