Device manufacturer, as written on reports
Medtronic Vascular: medical device reports filed with FDA
1,198 reports name it as the manufacturer of the device involved, 1999–2026.
- 1,198
- reports naming it as manufacturer
- 0% of all MAUDE reports
- 44
- reports, 12 months to August 2026
- 25 in the 12 months before
- 20.9%
- classified as malfunction
- 62.3% across all reports
- 11.2%
- classified as death, as reported
- 0.9% across all reports
1,198 medical device reports received by FDA give Medtronic Vascular as the manufacturer of the device involved, 0% of the MAUDE database, from May 1999 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.
44 reports arrived in the 12 months to August 2026, up 76% from 25 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 (66.4%), malfunction (20.9%) and death (11.2%). 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 |
|---|---|---|---|---|
| Medtronic Aneurx Bifurcated Stent Graft Flexible | System, endovascular graft, aortic aneurysm treatment | 182 | 0 | 9.7% |
| Aneurx Stent Graft With Xcelerant Delivery System | System, endovascular graft, aortic aneurysm treatment | 173 | 0 | 8.5% |
| Aneurx Stent Graft Flexible With Xpedient | System, endovascular graft, aortic aneurysm treatment | 135 | 0 | 11.7% |
| Aneurx Aaadvantage Stent Graft System | System, endovascular graft, aortic aneurysm treatment | 129 | 0 | 13.6% |
| Micra | Leadless pacemaker | 25 | 524 | 8.4% |
| Sentrant Introducer Sheath | Introducer, catheter | 21 | 41 | 15.2% |
| Synchromed El | Pump, infusion, implanted, programmable | 12 | 2 | 4.9% |
| Onyx Frontier | Coronary drug-eluting stent | 6 | 250 | 4.3% |
| Talent Abdominal Stent Graft System - Hydro | System, endovascular graft, aortic aneurysm treatment | 6 | 0 | 12% |
| Indura | Pump, infusion, implanted, programmable | 5 | 0 | 0.8% |
| Aneurx Aaadvantage Stent Graft System - Hydro | System, endovascular graft, aortic aneurysm treatment | 4 | 0 | 12.2% |
| Medtronic | Implantable cardioverter defibrillator (non-crt) | 4 | 17 | 4.4% |
| Talent Abdominal Stent Graft System | System, endovascular graft, aortic aneurysm treatment | 4 | 0 | 13.2% |
| Euphora Rx | Catheters, transluminal coronary angioplasty, percutaneous | 3 | 43 | 1.7% |
| Resolute Onyx Rx | Coronary drug-eluting stent | 3 | 88 | 8.7% |
| Synchromed | Pump, infusion, implanted, programmable | 3 | 3 | 3.2% |
| Drug Eluting Permanent Left Ventricular Lv Pacemaker Electrode | Drug eluting permanent left ventricular (lv) pacemaker electrode | 2 | 80 | 0.3% |
| Resolute Integrity Rx | Coronary drug-eluting stent | 2 | 70 | 7.9% |
| Admiral Xtreme | Catheter, angioplasty, peripheral, transluminal | 1 | 0 | 4.7% |
| Aneurx | System, endovascular graft, aortic aneurysm treatment | 1 | 0 | 9.6% |
| Aneurx Abdominal Stent Graft System | System, endovascular graft, aortic aneurysm treatment | 1 | 0 | 15.5% |
| Deep Brain Stimulation Lead | Stimulator, electrical, implanted, for parkinsonian tremor | 1 | 0 | 3.8% |
| Endeavor Rx Coronary Stent System | Coronary drug-eluting stent | 1 | 0 | 27% |
| Endeavor Rx Drug-Eluting Coronary Stent System | Coronary drug-eluting stent | 1 | 0 | 24.7% |
| Endurant Abdominal Stent Graft System | System, endovascular graft, aortic aneurysm treatment | 1 | 0 | 12.9% |
| Nc Sprinter Rx | Catheters, transluminal coronary angioplasty, percutaneous | 1 | 41 | 1.1% |
| Specify | Stimulator, spinal-cord, totally implanted for pain relief | 1 | 0 | 0% |
| Valiant Navion | System, endovascular graft, aortic aneurysm treatment | 1 | 40 | 17.4% |
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 | 867 | 72.4% |
| DQY | Catheter, percutaneous | 57 | 4.8% |
| FGE | Stents, drains and dilators for the biliary ducts | 55 | 4.6% |
| NIQ | Coronary drug-eluting stent | 54 | 4.5% |
| DYB | Introducer, catheter | 48 | 4% |
| LKK | Pump, infusion, implanted, programmable | 21 | 1.8% |
| DQX | Wire, guide, catheter | 17 | 1.4% |
| NFA | Temporary coronary saphenous vein bypass graft for embolic protection | 12 | 1% |
| LOX | Catheters, transluminal coronary angioplasty, percutaneous | 11 | 0.9% |
| DXC | Clamp, vascular | 8 | 0.7% |
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 Vascular reports
How many FDA device reports name Medtronic Vascular as manufacturer?
1,198 reports through August 2026, 44 of them in the latest 12 months.
Which of its brands appear most often?
Medtronic Aneurx Bifurcated Stent Graft Flexible (182), Aneurx Stent Graft With Xcelerant Delivery System (173), Aneurx Stent Graft Flexible With Xpedient (135), Aneurx Aaadvantage Stent Graft System (129) and Micra (25).
Which device types does it report on?
system, endovascular graft, aortic aneurysm treatment (72.4%), catheter, percutaneous (4.8%), stents, drains and dilators for the biliary ducts (4.6%) and coronary drug-eluting stent (4.5%).
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.