MEDTRONIC HEART VALVES DIVISION

Manufacturer adverse-event records for MEDTRONIC HEART VALVES DIVISION 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 · 2011–2026 · heavy-book · elevated Death-code · injury-heavy

Death-code intensity

MEDTRONIC HEART VALVES DIVISION carries an elevated Death-code share

Death-coded event_type rows are 3,661 of 42,898 (8.53% · elevated tercile among 443 manufacturers). Absolute volume is heavy-book.

What the Death-code reading shows for MEDTRONIC HEART VALVES DIVISION

The standout signal for MEDTRONIC HEART VALVES DIVISION is Death-code intensity: 8.53% of 42,898 reports (elevated tercile), while absolute volume is heavy-book.

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair MEDTRONIC HEART VALVES DIVISION 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 14 device types, led in this extract by Injury at 34,153 (79.6% of event_type total). Peak single-year volume reaches 7,547 reports across 15 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

42,898
Total Reports
3,661
Event-type Death
34,153
Injury Reports
14
Device Types

Event Types

Injury 34,153 (79.6%)
Malfunction 5,079 (11.8%)
Death 3,661 (8.5%)
3 (0.0%)
Other 2 (0.0%)

Patient Outcomes

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

Required Intervention 25,870 (44.5%)
R 7,248 (12.5%)
Hospitalization 5,042 (8.7%)
4,819 (8.3%)
H 4,470 (7.7%)
Life Threatening 3,466 (6.0%)
Death 3,111 (5.4%)
L 2,617 (4.5%)
D 576 (1.0%)
Disability 376 (0.6%)
S 296 (0.5%)
Other 132 (0.2%)
Congenital Anomaly 41 (0.1%)
O 14 (0.0%)
C 4 (0.0%)

Yearly Trend

11
2011: 1
13
2013: 2
14
2014: 903
15
2015: 1,329
16
2016: 2,003
17
2017: 2,350
18
2018: 2,954
19
2019: 3,449
20
2020: 3,652
21
2021: 3,441
22
2022: 3,663
23
2023: 5,440
24
2024: 7,547
25
2025: 5,943
26
2026: 221