PENUMBRA, INC.

Manufacturer adverse-event records for PENUMBRA, 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 · 2008–2026 · mid-book · elevated Death-code · balanced

Death-code intensity

PENUMBRA, INC. carries an elevated Death-code share

Death-coded event_type rows are 272 of 21,133 (1.29% · elevated tercile among 434 manufacturers). Absolute volume is mid-book.

What the Death-code reading shows for PENUMBRA, INC.

The standout signal for PENUMBRA, INC. is Death-code intensity: 1.29% of 21,133 reports (elevated tercile), while absolute volume is mid-book.

Mid-pack volume still shows a clear device fingerprint; the table below is the actionable layer for PENUMBRA, INC.. Event_type Death/Injury codes differ from patient-outcome rows - see methodology.

Reports span 14 device types, led in this extract by Malfunction at 18,637 (88.2% of event_type total). Peak single-year volume reaches 2,814 reports across 19 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

21,133
Total Reports
272
Event-type Death
2,190
Injury Reports
14
Device Types

Event Types

Malfunction 18,637 (88.2%)
Injury 2,190 (10.4%)
Death 272 (1.3%)
Other 28 (0.1%)
6 (0.0%)

Patient Outcomes

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

18,556 (85.5%)
Required Intervention 1,246 (5.7%)
Other 647 (3.0%)
R 305 (1.4%)
Death 259 (1.2%)
Life Threatening 215 (1.0%)
Hospitalization 163 (0.8%)
O 152 (0.7%)
L 96 (0.4%)
H 38 (0.2%)
D 21 (0.1%)
S 3 (0.0%)
Disability 3 (0.0%)
Congenital Anomaly 2 (0.0%)

Yearly Trend

08
2008: 18
09
2009: 107
10
2010: 575
11
2011: 305
12
2012: 358
13
2013: 556
14
2014: 942
15
2015: 1,366
16
2016: 1,904
17
2017: 2,329
18
2018: 2,553
19
2019: 2,469
20
2020: 2,430
21
2021: 2,814
22
2022: 649
23
2023: 617
24
2024: 453
25
2025: 438
26
2026: 250