Device manufacturer, as written on reports

Medtronic Cardiovascular: medical device reports filed with FDA

4,038 reports name it as the manufacturer of the device involved, 2007–2019.

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.

4,038
reports naming it as manufacturer: 0% of all MAUDE reports; 0
reports, 12 months to August 2026: 0 in the 12 months before; 11.4%
classified as malfunction: 62.3% across all reports; 16.5%
classified as death, as reported: 0.9% across all reports

4,038 medical device reports received by FDA give Medtronic Cardiovascular as the manufacturer of the device involved, 0% of the MAUDE database, from December 2007 to August 2019. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

0 reports arrived in the 12 months to August 2026, and none 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 (72%), death (16.5%) and malfunction (11.4%). 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
Talent Abdominal Stent Graft System - Hydro	System, endovascular graft, aortic aneurysm treatment	403	0	12%
Talent Thoracic Stent Graft System	System, endovascular graft, aortic aneurysm treatment	343	0	26.7%
Aneurx	System, endovascular graft, aortic aneurysm treatment	338	0	9.6%
Talent Abdominal Stent Graft System	System, endovascular graft, aortic aneurysm treatment	260	0	13.2%
Aneurx Aaadvantage Stent Graft System	System, endovascular graft, aortic aneurysm treatment	214	0	13.6%
Aneurx Aaadvantage Stent Graft System - Hydro	System, endovascular graft, aortic aneurysm treatment	169	0	12.2%
Aneurx Abdominal Stent Graft System	System, endovascular graft, aortic aneurysm treatment	130	0	15.5%
Medtronic Aneurx Bifurcated Stent Graft Flexible	System, endovascular graft, aortic aneurysm treatment	126	0	9.7%
Aneurx Stent Graft With Xcelerant Delivery System	System, endovascular graft, aortic aneurysm treatment	90	0	8.5%
Talent Aaa	System, endovascular graft, aortic aneurysm treatment	84	0	12.8%
Talent	System, endovascular graft, aortic aneurysm treatment	78	0	17.4%
Talent Taa	System, endovascular graft, aortic aneurysm treatment	74	0	44.4%
Aneurx Stent Graft Flexible With Xpedient	System, endovascular graft, aortic aneurysm treatment	73	0	11.7%
Aneurx Stent Graft System	System, endovascular graft, aortic aneurysm treatment	68	0	11.1%
Valiant	System, endovascular graft, aortic aneurysm treatment	62	0	28.2%
Sentrant Introducer Sheath	Introducer, catheter	57	41	15.2%
Talent Aaa Stent Graft	System, endovascular graft, aortic aneurysm treatment	57	8	11.7%
Endurant	System, endovascular graft, aortic aneurysm treatment	53	0	14.7%
Talent Taa Stent Graft	System, endovascular graft, aortic aneurysm treatment	35	12	14.2%
Endeavor Rx Coronary Stent System	Coronary drug-eluting stent	14	0	27%
Endeavor Sprint Rx Coronary Stent System	Coronary drug-eluting stent	14	0	17.4%
Endurant Abdominal Stent Graft System	System, endovascular graft, aortic aneurysm treatment	11	0	12.9%
Valiant Captivia	System, endovascular graft, aortic aneurysm treatment	11	6	21.6%
Endo Anchor System - Heli-Fx Aaa	Endovascular suturing system	8	50	10.4%
Reliant Balloon	Catheter, percutaneous	8	11	19.7%
Endurant Iliac Stent Graft	System, endovascular graft, aortic aneurysm treatment	6	11	13%
Endurant Stent Graft System	System, endovascular graft, aortic aneurysm treatment	5	0	15.4%
Endurant Bifurcated Stent Graft	System, endovascular graft, aortic aneurysm treatment	3	13	13.8%
Endurant Stent Graft	System, endovascular graft, aortic aneurysm treatment	3	56	10%
Valiant Stent Graft	System, endovascular graft, aortic aneurysm treatment	2	31	11.6%

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	3,616	89.5%
NIQ	Coronary drug-eluting stent	110	2.7%
DYB	Introducer, catheter	73	1.8%
DQY	Catheter, percutaneous	72	1.8%
FGE	Stents, drains and dilators for the biliary ducts	56	1.4%
DQX	Wire, guide, catheter	50	1.2%
NIO	Stent, iliac	41	1%
OTD	Endovascular suturing system	8	0.2%
ITX	Transducer, ultrasonic, diagnostic	5	0.1%
MAF	Stent, coronary	3	0.1%

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

Death16.5%666

Injury72%2,907

Malfunction11.4%460

Other0%1

Not given0.1%4

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

Questions about Medtronic Cardiovascular reports

How many FDA device reports name Medtronic Cardiovascular as manufacturer?

4,038 reports through August 2026, 0 of them in the latest 12 months.

Which of its brands appear most often?

Talent Abdominal Stent Graft System - Hydro (403), Talent Thoracic Stent Graft System (343), Aneurx (338), Talent Abdominal Stent Graft System (260) and Aneurx Aaadvantage Stent Graft System (214).

Which device types does it report on?

system, endovascular graft, aortic aneurysm treatment (89.5%), coronary drug-eluting stent (2.7%), introducer, catheter (1.8%) and catheter, percutaneous (1.8%).

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.