BOSTON SCIENTIFIC - MAPLE GROVE

Manufacturer adverse-event records for BOSTON SCIENTIFIC - MAPLE GROVE 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 · 2004–2018 · heavy-book · elevated Death-code · balanced

Death-code intensity

BOSTON SCIENTIFIC - MAPLE GROVE carries an elevated Death-code share

Death-coded event_type rows are 1,025 of 26,804 (3.82% · elevated tercile among 443 manufacturers). Absolute volume is heavy-book.

What the Death-code reading shows for BOSTON SCIENTIFIC - MAPLE GROVE

The standout signal for BOSTON SCIENTIFIC - MAPLE GROVE is Death-code intensity: 3.82% of 26,804 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 - MAPLE GROVE 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 17,820 (66.5% of event_type total). Peak single-year volume reaches 4,088 reports across 13 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

26,804
Total Reports
1,025
Event-type Death
7,952
Injury Reports
20
Device Types

Event Types

Malfunction 17,820 (66.5%)
Injury 7,952 (29.7%)
Death 1,025 (3.8%)
6 (0.0%)
Other 1 (0.0%)

Patient Outcomes

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

17,898 (63.9%)
Required Intervention 5,278 (18.8%)
Other 1,525 (5.4%)
R 1,103 (3.9%)
Hospitalization 1,055 (3.8%)
Death 1,037 (3.7%)
O 50 (0.2%)
H 42 (0.1%)
Life Threatening 9 (0.0%)
S 7 (0.0%)
L 3 (0.0%)
Disability 2 (0.0%)

Yearly Trend

04
2004: 2
05
2005: 3
06
2006: 4
09
2009: 6
10
2010: 1,981
11
2011: 2,826
12
2012: 3,406
13
2013: 2,914
14
2014: 2,545
15
2015: 2,863
16
2016: 4,088
17
2017: 3,989
18
2018: 2,177