MEDTRONIC MILACA, INC.

Manufacturer adverse-event records for MEDTRONIC MILACA, INC. 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 · 2001–2025 · thin-book · typical Death-code · balanced

Volume signature

MEDTRONIC MILACA, INC. is a thinner MAUDE footprint

MEDTRONIC MILACA, INC. accounts for 6,066 FDA MAUDE reports (#324 of 443, thin-book tercile). Death-coded event_type share is 0.08% (typical); Injury share 10.1% (balanced).

What the volume reading shows for MEDTRONIC MILACA, INC.

The standout signal for MEDTRONIC MILACA, INC. is filing volume: 6,066 adverse-event reports in FDA MAUDE (#324 of 443, thin-book). Death-coded event_type share sits at 0.08% (typical).

As a thinner-book manufacturer, a handful of device families can swing the totals; open the device table rather than reading the company headline alone. Event_type counts are not the same population as Patient Outcomes.

Reports span 14 device types, led in this extract by Malfunction at 5,449 (89.8% of event_type total). Peak single-year volume reaches 1,604 reports across 18 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

6,066
Total Reports
5
Event-type Death
611
Injury Reports
14
Device Types

Event Types

Malfunction 5,449 (89.8%)
Injury 611 (10.1%)
Death 5 (0.1%)
1 (0.0%)

Patient Outcomes

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

5,315 (85.0%)
Required Intervention 397 (6.3%)
Other 182 (2.9%)
R 145 (2.3%)
Life Threatening 105 (1.7%)
Hospitalization 58 (0.9%)
L 44 (0.7%)
Death 5 (0.1%)
D 1 (0.0%)
H 1 (0.0%)
Congenital Anomaly 1 (0.0%)

Yearly Trend

01
2001: 1
08
2008: 1
10
2010: 3
11
2011: 39
12
2012: 182
13
2013: 1,604
14
2014: 1,363
15
2015: 1,131
16
2016: 331
17
2017: 346
18
2018: 243
19
2019: 224
20
2020: 144
21
2021: 136
22
2022: 136
23
2023: 85
24
2024: 65
25
2025: 32