Device manufacturer, as written on reports

W L Gore & Associates: medical device reports filed with FDA

31,917 reports name it as the manufacturer of the device involved, 1994–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

31,917
reports naming it as manufacturer: 0.1% of all MAUDE reports; 2,876
reports, 12 months to August 2026: 2,577 in the 12 months before; 11%
classified as malfunction: 62.3% across all reports; 5.6%
classified as death, as reported: 0.9% across all reports

31,917 medical device reports received by FDA give W L Gore & Associates as the manufacturer of the device involved, 0.1% of the MAUDE database, from March 1994 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

2,876 reports arrived in the 12 months to August 2026, up 12% from 2,577 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are injury (83.3%), malfunction (11%) and death (5.6%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Brands named most often

Brand	Device type	Reports	Latest 12 months	Classified as death
GORE EXCLUDER AAA Endoprosthesis	System, endovascular graft, aortic aneurysm treatment	9,478	633	4.8%
Gore Tag Thoracic Endoprosthesis	System, endovascular graft, aortic aneurysm treatment	2,797	4	14.7%
GORE VIABAHN VBX Balloon Expandable Endoprosthesis	Iliac covered stent, arterial	1,484	295	4.9%
GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System	System, endovascular graft, aortic aneurysm treatment	1,474	311	7.7%
GORE DrySeal Flex Introducer Sheath	Introducer, catheter	1,168	283	5.3%
GORE VIABAHN Endoprosthesis	Stent, superficial femoral artery	978	18	5.8%
Gore Dualmesh Plus Biomaterial	Mesh, surgical, polymeric	924	5	0.2%
GORE VIABAHN Endoprosthesis with HEPARIN Bioactive Surface	Stent, superficial femoral artery	906	174	2.1%
GORE EXCLUDER Iliac Branch Endoprosthesis	System, endovascular graft, aortic aneurysm treatment	751	158	4%
GORE EXCLUDER Conformable AAA Endoprosthesis	System, endovascular graft, aortic aneurysm treatment	750	222	4.8%
GORE DUALMESH Biomaterial	Mesh, surgical, polymeric	747	8	0.1%
Aortic Excluder Aaa Endoprosthesis C3	System, endovascular graft, aortic aneurysm treatment	667	0	4.2%
GORE CARDIOFORM Septal Occluder	Transcatheter septal occluder	525	80	1.3%
Gore Propaten Vascular Graft	Prosthesis, vascular graft, of 6mm and greater diameter	502	13	2.6%
Conformable Gore Tagthoracic Endoprosthesis	System, endovascular graft, aortic aneurysm treatment	407	7	6.1%
Aortic Tag Thoracic Endoprosthesis Ctag	System, endovascular graft, aortic aneurysm treatment	399	0	8.8%
GORE TAG Thoracic Branch Endoprosthesis	System, endovascular graft, aortic aneurysm treatment	375	190	9.5%
Gore Dryseal Sheath	Introducer, catheter	365	0	8.6%
Gore Viabahn Endoprosthesis - 3	System, endovascular graft, arteriovenous (av) dialysis access circuit stenosis treatment	354	0	3.1%
Excluder Bifurcated Endoprosthesis	System, endovascular graft, aortic aneurysm treatment	346	0	7.7%
GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface	Stent, superficial femoral artery	341	91	0.6%
GORE ACUSEAL Vascular Graft	Prosthesis, vascular graft, of 6mm and greater diameter	337	35	0.3%
Aortic Excluder Aaa Endoprosthesis Low Profile	System, endovascular graft, aortic aneurysm treatment	311	0	2.9%
GORE CARDIOFORM ASD Occluder	Transcatheter septal occluder	271	57	0.7%
Gore Helex Septal Occluder	Transcatheter septal occluder	270	0	0.4%
Gore Excluderaaa Endoprosthesis	System, endovascular graft, aortic aneurysm treatment	261	3	4.2%
Gore-Tex Suture	Suture, nonabsorbable, synthetic, polypropylene	228	16	1.2%
Aortic Introducer Sheath Dryseal Flex Ver 4 0	Introducer, catheter	165	0	3%
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis	—	162	102	14.2%
GORE Molding & Occlusion Balloon Catheter	Catheter, percutaneous	158	30	5.5%

Brands with a page on this site, ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Device types

Product code	Device type	Reports	Share
MIH	System, endovascular graft, aortic aneurysm treatment	19,322	60.5%
FTL	Mesh, surgical, polymeric	2,356	7.4%
NIP	Stent, superficial femoral artery	1,992	6.2%
DYB	Introducer, catheter	1,951	6.1%
DSY	Prosthesis, vascular graft, of 6mm and greater diameter	1,483	4.6%
PRL	Iliac covered stent, arterial	1,338	4.2%
MLV	Transcatheter septal occluder	1,093	3.4%
PFV	System, endovascular graft, arteriovenous (av) dialysis access circuit stenosis treatment	629	2%
GAW	Suture, nonabsorbable, synthetic, polypropylene	216	0.7%
MIR	Shunt, portosystemic, endoprosthesis	194	0.6%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type

Death5.6%1,772

Injury83.3%26,582

Malfunction11%3,501

Other0.1%36

Not given0.1%26

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about W L Gore & Associates reports

How many FDA device reports name W L Gore & Associates as manufacturer?

31,917 reports through August 2026, 2,876 of them in the latest 12 months.

Which of its brands appear most often?

GORE EXCLUDER AAA Endoprosthesis (9,478), Gore Tag Thoracic Endoprosthesis (2,797), GORE VIABAHN VBX Balloon Expandable Endoprosthesis (1,484), GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System (1,474) and GORE DrySeal Flex Introducer Sheath (1,168).

Which device types does it report on?

system, endovascular graft, aortic aneurysm treatment (60.5%), mesh, surgical, polymeric (7.4%), stent, superficial femoral artery (6.2%) and introducer, catheter (6.1%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.