HOLOGIC, INC

Manufacturer adverse-event records for HOLOGIC, 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 · 2002–2026 · thin-book · typical Death-code · injury-heavy

Volume signature

HOLOGIC, INC is a thinner MAUDE footprint

HOLOGIC, INC accounts for 3,583 FDA MAUDE reports (#437 of 443, thin-book tercile). Death-coded event_type share is 0.67% (typical); Injury share 57.9% (injury-heavy).

What the volume reading shows for HOLOGIC, INC

The standout signal for HOLOGIC, INC is filing volume: 3,583 adverse-event reports in FDA MAUDE (#437 of 443, thin-book). Death-coded event_type share sits at 0.67% (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 20 device types, led in this extract by Injury at 2,075 (57.9% of event_type total). Peak single-year volume reaches 796 reports across 20 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

3,583
Total Reports
24
Event-type Death
2,075
Injury Reports
20
Device Types

Event Types

Injury 2,075 (57.9%)
Malfunction 1,428 (39.9%)
39 (1.1%)
Death 24 (0.7%)
Other 17 (0.5%)

Patient Outcomes

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

Other 1,626 (38.6%)
1,450 (34.4%)
R 325 (7.7%)
Hospitalization 237 (5.6%)
O 231 (5.5%)
Required Intervention 218 (5.2%)
H 80 (1.9%)
Death 25 (0.6%)
L 10 (0.2%)
Life Threatening 10 (0.2%)
S 5 (0.1%)

Yearly Trend

02
2002: 1
05
2005: 1
09
2009: 4
10
2010: 5
11
2011: 4
12
2012: 16
13
2013: 11
14
2014: 12
15
2015: 84
16
2016: 233
17
2017: 130
18
2018: 158
19
2019: 294
20
2020: 145
21
2021: 67
22
2022: 326
23
2023: 542
24
2024: 632
25
2025: 796
26
2026: 122