PlainHospital

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 3,686 of 43,436 (8.49% · elevated tercile among 434 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: 8.49% of 43,436 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 15 device types, led in this extract by Injury at 34,588 (79.6% of event_type total). Peak single-year volume reaches 7,536 reports across 15 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

43,436
Total Reports
3,686
Event-type Death
34,588
Injury Reports
15
Device Types

Event Types

Injury 34,588 (79.6%)
Malfunction 5,157 (11.9%)
Death 3,686 (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 25,997 (44.2%)
R 7,391 (12.6%)
Hospitalization 5,145 (8.8%)
4,870 (8.3%)
H 4,593 (7.8%)
Life Threatening 3,538 (6.0%)
Death 3,116 (5.3%)
L 2,701 (4.6%)
D 578 (1.0%)
Disability 375 (0.6%)
S 295 (0.5%)
Other 134 (0.2%)
Congenital Anomaly 41 (0.1%)
O 14 (0.0%)
C 4 (0.0%)

Devices (15)

Device Reports
Aortic Valve, Prosthesis, Percutaneously Delivered 28,310
Replacement Heart-Valve 5,524
Heart-Valve, Non-Allograft Tissue 4,698
Ring, Annuloplasty 2,453
Pulmonary Valve Prosthesis Percutaneously Delivered 1,198
Pulmonic Valved Conduit 804
Heart-Valve, Mechanical 203
Wire, Guide, Catheter 178
Electrode, Pacemaker, Temporary 50
Instruments, Surgical, Cardiovascular 6
Computer, Diagnostic, Programmable 4
Timer, Clot, Automated 4
Introducer, Catheter 2
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass 1
Sizer, Heart-Valve, Prosthesis 1

Yearly Trend

11
2011: 1
13
2013: 2
14
2014: 903
15
2015: 1,329
16
2016: 2,002
17
2017: 2,350
18
2018: 2,954
19
2019: 3,449
20
2020: 3,652
21
2021: 3,442
22
2022: 3,662
23
2023: 5,439
24
2024: 7,536
25
2025: 5,918
26
2026: 797

Read our methodology - how this data is sourced, computed, and verified.