Device manufacturer, as written on reports
Medtronic Cardiovascular Santa Rosa: medical device reports filed with FDA
2,265 reports name it as the manufacturer of the device involved, 2007–2025.
- 2,265
- reports naming it as manufacturer
- 0% of all MAUDE reports
- 0
- reports, 12 months to August 2026
- 11 in the 12 months before
- 10.3%
- classified as malfunction
- 62.3% across all reports
- 13.6%
- classified as death, as reported
- 0.9% across all reports
2,265 medical device reports received by FDA give Medtronic Cardiovascular Santa Rosa as the manufacturer of the device involved, 0% of the MAUDE database, from December 2007 to July 2025. 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, against 11 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 (76.1%), death (13.6%) and malfunction (10.3%). 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 |
|---|---|---|---|---|
| Aneurx | System, endovascular graft, aortic aneurysm treatment | 251 | 0 | 9.6% |
| Aneurx Abdominal Stent Graft System | System, endovascular graft, aortic aneurysm treatment | 156 | 0 | 15.5% |
| Aneurx Stent Graft System | System, endovascular graft, aortic aneurysm treatment | 130 | 0 | 11.1% |
| Endo Anchor System - Heli-Fx Aaa | Endovascular suturing system | 86 | 50 | 10.4% |
| Talent Aaa | System, endovascular graft, aortic aneurysm treatment | 71 | 0 | 12.8% |
| Talent Abdominal Stent Graft System | System, endovascular graft, aortic aneurysm treatment | 70 | 0 | 13.2% |
| Endurant | System, endovascular graft, aortic aneurysm treatment | 63 | 0 | 14.7% |
| Endurant Abdominal Stent Graft System | System, endovascular graft, aortic aneurysm treatment | 58 | 0 | 12.9% |
| Talent Aaa Stent Graft | System, endovascular graft, aortic aneurysm treatment | 52 | 8 | 11.7% |
| Medtronic Aneurx Bifurcated Stent Graft Flexible | System, endovascular graft, aortic aneurysm treatment | 48 | 0 | 9.7% |
| Talent Thoracic Stent Graft System | System, endovascular graft, aortic aneurysm treatment | 47 | 0 | 26.7% |
| Talent | System, endovascular graft, aortic aneurysm treatment | 41 | 0 | 17.4% |
| Talent Taa Stent Graft | System, endovascular graft, aortic aneurysm treatment | 33 | 12 | 14.2% |
| Endurant Stent Graft System | System, endovascular graft, aortic aneurysm treatment | 26 | 0 | 15.4% |
| Endurant Stent Graft | System, endovascular graft, aortic aneurysm treatment | 25 | 56 | 10% |
| Endurant Bifurcated Stent Graft | System, endovascular graft, aortic aneurysm treatment | 20 | 13 | 13.8% |
| Endurant Iliac Stent Graft | System, endovascular graft, aortic aneurysm treatment | 16 | 11 | 13% |
| Talent Taa | System, endovascular graft, aortic aneurysm treatment | 16 | 0 | 44.4% |
| Aneurx Stent Graft With Xcelerant Delivery System | System, endovascular graft, aortic aneurysm treatment | 15 | 0 | 8.5% |
| Talent Abdominal Stent Graft System - Hydro | System, endovascular graft, aortic aneurysm treatment | 15 | 0 | 12% |
| Sentrant Introducer Sheath | Introducer, catheter | 14 | 41 | 15.2% |
| Aneurx Aaadvantage Stent Graft System | System, endovascular graft, aortic aneurysm treatment | 11 | 0 | 13.6% |
| Valiant | System, endovascular graft, aortic aneurysm treatment | 10 | 0 | 28.2% |
| Endeavor Rx | Coronary drug-eluting stent | 7 | 0 | 35.3% |
| Aneurx Aaadvantage Stent Graft System - Hydro | System, endovascular graft, aortic aneurysm treatment | 5 | 0 | 12.2% |
| Complete Se Iliac | Stent, iliac | 5 | 0 | 5% |
| Endeavor Sprint Rx Coronary Stent System | Coronary drug-eluting stent | 4 | 0 | 17.4% |
| Resolute Integrity Rx | Coronary drug-eluting stent | 4 | 70 | 7.9% |
| Aneurx Stent Graft Flexible With Xpedient | System, endovascular graft, aortic aneurysm treatment | 3 | 0 | 11.7% |
| Endeavor Rx Coronary Stent System | Coronary drug-eluting stent | 1 | 0 | 27% |
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 | 2,088 | 92.2% |
| OTD | Endovascular suturing system | 93 | 4.1% |
| NIO | Stent, iliac | 29 | 1.3% |
| NIQ | Coronary drug-eluting stent | 24 | 1.1% |
| DYB | Introducer, catheter | 14 | 0.6% |
| MAF | Stent, coronary | 5 | 0.2% |
| FGE | Stents, drains and dilators for the biliary ducts | 4 | 0.2% |
| DQY | Catheter, percutaneous | 3 | 0.1% |
| NIP | Stent, superficial femoral artery | 3 | 0.1% |
| DQX | Wire, guide, catheter | 2 | 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
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 Santa Rosa reports
How many FDA device reports name Medtronic Cardiovascular Santa Rosa as manufacturer?
2,265 reports through August 2026, 0 of them in the latest 12 months.
Which of its brands appear most often?
Aneurx (251), Aneurx Abdominal Stent Graft System (156), Aneurx Stent Graft System (130), Endo Anchor System - Heli-Fx Aaa (86) and Talent Aaa (71).
Which device types does it report on?
system, endovascular graft, aortic aneurysm treatment (92.2%), endovascular suturing system (4.1%), stent, iliac (1.3%) and coronary drug-eluting stent (1.1%).
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.