PlainHospital

W. L. GORE & ASSOCIATES, INC.

Manufacturer adverse-event records for W. L. GORE & ASSOCIATES, 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 · 1994–2026 · mid-book · elevated Death-code · injury-heavy

Death-code intensity

W. L. GORE & ASSOCIATES, INC. carries an elevated Death-code share

Death-coded event_type rows are 568 of 13,469 (4.22% · elevated tercile among 443 manufacturers). Absolute volume is mid-book.

What the Death-code reading shows for W. L. GORE & ASSOCIATES, INC.

The standout signal for W. L. GORE & ASSOCIATES, INC. is Death-code intensity: 4.22% of 13,469 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 W. L. GORE & ASSOCIATES, INC.. Event_type Death/Injury codes differ from patient-outcome rows - see methodology.

Reports span 20 device types, led in this extract by Injury at 11,153 (82.8% of event_type total). Peak single-year volume reaches 2,722 reports across 27 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

13,469
Total Reports
568
Event-type Death
11,153
Injury Reports
20
Device Types

Event Types

Injury 11,153 (82.8%)
Malfunction 1,744 (12.9%)
Death 568 (4.2%)
3 (0.0%)
Other 1 (0.0%)

Patient Outcomes

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

Required Intervention 6,527 (35.4%)
Hospitalization 2,577 (14.0%)
R 2,401 (13.0%)
Other 2,194 (11.9%)
1,583 (8.6%)
H 1,219 (6.6%)
O 1,136 (6.2%)
Death 429 (2.3%)
D 139 (0.8%)
L 79 (0.4%)
Life Threatening 68 (0.4%)
Disability 44 (0.2%)
S 40 (0.2%)

Devices (20)

Device Reports
System, Endovascular Graft, Aortic Aneurysm Treatment 7,799
Iliac Covered Stent, Arterial 1,115
Stent, Superficial Femoral Artery 1,056
Introducer, Catheter 965
Mesh, Surgical, Polymeric 801
Transcatheter Septal Occluder 572
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter 407
System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment 150
Catheter, Percutaneous 133
Shunt, Portosystemic, Endoprosthesis 125
Endovascular System For Treatment Of Thoracoabdominal And Pararenal Aortic Lesions 95
Suture, Nonabsorbable, Synthetic, Polypropylene 74
Catheter, Intravascular Occluding, Temporary 57
Mesh, Surgical 35
Stents, Drains And Dilators For The Biliary Ducts 35
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene 21
Mesh, Surgical, Absorbable, Abdominal Hernia 11
Dura Substitute 3
Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery 3
Laparoscope, General & Plastic Surgery 2

Yearly Trend

94
1994: 1
96
1996: 1
98
1998: 1
99
1999: 1
04
2004: 1
05
2005: 1
06
2006: 162
07
2007: 246
08
2008: 176
09
2009: 51
10
2010: 31
11
2011: 45
12
2012: 21
13
2013: 38
14
2014: 8
15
2015: 6
16
2016: 3
17
2017: 7
18
2018: 4
19
2019: 7
20
2020: 1,062
21
2021: 2,032
22
2022: 1,957
23
2023: 2,133
24
2024: 2,371
25
2025: 2,722
26
2026: 381

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