Reported Reactions

Adverse event reports that FDA received

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Medtronic Ireland medical device reports that give this manufacturer

Name type
Device manufacturer, as written on reports

What a report is

A report is not proof that the device was the cause of the event.

FDA says:

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.

Source: openFDA, Device Adverse Event Overview, section "Responsible use of the data". The site read the page on . The data have the reports that FDA received through .

FDA also says:

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.

Source: openFDA, Device Adverse Event Overview. The site read the page on .

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.

Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .

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.

Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on .

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

Reports on file

From April 2000 to September 2026, FDA received 66,820 medical device reports that give Medtronic Ireland as the manufacturer. A manufacturer name is as written on the report, so a subsidiary or a different spelling can be a separate name.

FDA received 6,168 reports in the 12 months to September 2026 and 5,609 in the 12 months before. FDA releases MAUDE data every month. Reports can arrive months after an event, so the newest months grow in later releases.

Of the 3,444,740 device reports that FDA received in the 12 months to September 2026, 6,168 (0.2%) give Medtronic Ireland as the manufacturer. Manufacturer reports were 99.9% of the reports that name this manufacturer and 94.9% of all device reports.

The number of people who use the product is not in the data. A count is not a rate.

Why manufacturers report

FDA says:

Mandatory reporters (that is, manufacturers, device user facilities, and importers) are required to submit to the FDA certain types of reports for adverse events and product problems about medical devices.

Source: FDA Center for Devices and Radiological Health, Medical Device Reporting (MDR): How to Report Medical Device Problems. Content current as of . The site read the page on .

Data version

openFDA MAUDE release of 23 Oct 2026. Reports received through 30 Sep 2026.

Brand names

The table has the 61 brand pages with 5 or more reports that give this manufacturer. 63 brand pages have a report in all. The rows are in order of name. A brand page with fewer reports is not in the table.

FDA says:

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.

Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .

Brand names in the reports that give Medtronic Ireland as the manufacturer, in order of name
Brand nameProduct codeReportsReports, 12 months to September 2026
AfferaPercutaneous cardiac ablation catheter for treatment of atrial fibrillation with irreversible electroporation377996
AneurxSystem, endovascular graft, aortic aneurysm treatment930
Aneurx Aaadvantage Stent Graft SystemSystem, endovascular graft, aortic aneurysm treatment100
Aneurx Aaadvantage Stent Graft System - HydroSystem, endovascular graft, aortic aneurysm treatment130
Aneurx Abdominal Stent Graft SystemSystem, endovascular graft, aortic aneurysm treatment200
Assurant CobaltStent, iliac1600
AttainPermanent pacemaker electrode150
Attain CommandCatheter, percutaneous10711
Complete Se IliacStent, iliac3010
DeflectCatheter, percutaneous895240
Endeavor Resolute RxCoronary drug-eluting stent1,4600
Endeavor Resolute Rx Coronary Stent SystemCoronary drug-eluting stent890
Endeavor RxCoronary drug-eluting stent3420
Endeavor Rx Coronary Stent SystemCoronary drug-eluting stent850
Endeavor Sprint RxCoronary drug-eluting stent2,3990
Endeavor Sprint Rx Coronary Stent SystemCoronary drug-eluting stent7410
Endo Anchor System - Heli-Fx AaaEndovascular suturing system66848
EndurantSystem, endovascular graft, aortic aneurysm treatment1,7320
Endurant Abdominal Stent Graft SystemSystem, endovascular graft, aortic aneurysm treatment7460
Endurant Bifurcated Stent GraftSystem, endovascular graft, aortic aneurysm treatment58013
Endurant Iis Bifurcated Stent GraftSystem, endovascular graft, aortic aneurysm treatment1,711121
Endurant Iliac Stent GraftSystem, endovascular graft, aortic aneurysm treatment46611
Endurant Stent GraftSystem, endovascular graft, aortic aneurysm treatment1,43250
Endurant Stent Graft SystemSystem, endovascular graft, aortic aneurysm treatment2540
Evolut Fx DcsAortic valve, prosthesis, percutaneously delivered996818
Evolut Pro Plus DcsAortic valve, prosthesis, percutaneously delivered8273
FlexCath Contour Steerable SheathCatheter, steerable858372
Hawkone 6frCatheter, peripheral, atherectomy50230
In Pact Admiral Paclitaxel-Eluting Pta Balloon CatheterDrug-eluting peripheral transluminal angioplasty catheter90599
In Pact Av AccessDrug-eluting peripheral transluminal angioplasty catheter66785
In Pact PacificDrug-eluting peripheral transluminal angioplasty catheter1400
Integrity RxStent, coronary4930
MicraLeadless pacemaker6,737496
Micra AVLeadless pacemaker4,204253
Micra AV2Leadless pacemaker3,1111,453
Micra VR2Leadless pacemaker910411
Nc Sprinter RxCatheters, transluminal coronary angioplasty, percutaneous1138
Onyx FrontierCoronary drug-eluting stent1,016238
Onyx TruCorCoronary drug-eluting stent211132
Reliant BalloonCatheter, percutaneous2039
Reliant Stent Graft Balloon Catheter -OusCatheter, percutaneous8517
Resolute Integrity RxCoronary drug-eluting stent4,69866
Resolute Onyx RxCoronary drug-eluting stent5,80178
Sentrant Introducer SheathIntroducer, catheter24439
Sprinter Legend RxCatheters, transluminal coronary angioplasty, percutaneous1422
TalentSystem, endovascular graft, aortic aneurysm treatment880
Talent AaaSystem, endovascular graft, aortic aneurysm treatment650
Talent Aaa Stent GraftSystem, endovascular graft, aortic aneurysm treatment1378
Talent Abdominal Stent Graft SystemSystem, endovascular graft, aortic aneurysm treatment280
Talent Abdominal Stent Graft System - HydroSystem, endovascular graft, aortic aneurysm treatment180
Talent TaaSystem, endovascular graft, aortic aneurysm treatment500
Talent Taa Stent GraftSystem, endovascular graft, aortic aneurysm treatment358
Talent Thoracic Stent Graft SystemSystem, endovascular graft, aortic aneurysm treatment710
ValiantSystem, endovascular graft, aortic aneurysm treatment4370
Valiant CaptiviaSystem, endovascular graft, aortic aneurysm treatment4799
Valiant Captivia - CWSystem, endovascular graft, aortic aneurysm treatment57122
Valiant Captivia - FFSystem, endovascular graft, aortic aneurysm treatment1,52483
Valiant Captivia UnkSystem, endovascular graft, aortic aneurysm treatment20338
Valiant NavionSystem, endovascular graft, aortic aneurysm treatment1,14138
Valiant Stent GraftSystem, endovascular graft, aortic aneurysm treatment47228
Vena Seal Closure SystemAgent, occluding, vascular, permanent1,00883

Device types

The table has the 21 device types with 5 or more reports that give this manufacturer. The rows are in order of name.

FDA says:

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.

Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .

Device types in the reports that give Medtronic Ireland as the manufacturer, in order of name
Device typeProduct codeReports
Agent, occluding, vascular, permanentPJQ1,165
Aortic valve, prosthesis, percutaneously deliveredNPT1,160
Catheter, flow directedDYG29
Catheter, percutaneousDQY2,532
Catheter, peripheral, atherectomyMCW878
Catheter, steerableDRA860
Catheters, transluminal coronary angioplasty, percutaneousLOX218
Coronary drug-eluting stentNIQ17,569
Drug-coated peripheral transluminal angioplasty catheterPRC288
Drug-eluting peripheral transluminal angioplasty catheterONU1,632
Endovascular suturing systemOTD633
Implantable cardioverter defibrillator (non-crt)LWS7
Introducer, catheterDYB1,171
Leadless pacemakerPNJ14,087
Percutaneous cardiac ablation catheter for treatment of atrial fibrillation with irreversible electroporationQZI321
Stent, coronaryMAF928
Stent, iliacNIO497
Stent, superficial femoral arteryNIP69
Stents, drains and dilators for the biliary ductsFGE35
System, endovascular graft, aortic aneurysm treatmentMIH22,036
Wire, guide, catheterDQX6

Reports by month

Reports that give Medtronic Ireland as the manufacturer, by month, five years to September 2026
05001,00020222023202420252026

FDA releases MAUDE data every month. Reports can arrive months after an event, so the newest months grow in later releases.

Event type

Event type in the reports that give Medtronic Ireland as the manufacturer
Event typeReportsShare
Death6,6169.9%
Injury34,01550.9%
Malfunction26,16839.2%
Other7under 0.1%
Not given14under 0.1%

The event type is the classification that the reporter gave. FDA does not verify it.

Official pages

The site checked these addresses on . The links open in a new tab.

Cite this page

Reported Reactions. Medtronic Ireland: medical device reports that give this manufacturer. https://reportedreactions.com/manufacturer/medtronic-ireland/ Source: U.S. Food and Drug Administration, openFDA Device Adverse Event (MAUDE) files, release of . Reports received through .

Where the data come from

The counts come from the openFDA Device Adverse Event (MAUDE) bulk files, release of 23 Oct 2026. The files have the reports that FDA received through 30 Sep 2026. Brand names, generic names and manufacturer names are as written on the reports. The names of the product codes come from the device classification of FDA.

The site removes company suffixes (Inc., LLC, GmbH and similar) before it counts a manufacturer name. A name that reads as a person and not as an organisation is not published. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Does a large count say something about the manufacturer?

Not by itself. FDA says:

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.

Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .

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.

Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .

What event types do the reports record?

Death (6,616), injury (34,015), malfunction (26,168) and other (7). The event type is the classification that the reporter gave. FDA does not verify it.

Why can one company have more than one page?

The manufacturer field is free text on the report. This page counts the 66,820 reports with the name Medtronic Ireland after the site removes company suffixes. A subsidiary, a plant or a different spelling is a separate name.

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