Device manufacturer, as written on reports

Medtronic Ireland: medical device reports filed with FDA

66,617 reports name it as the manufacturer of the device involved, 2000–2026.

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.

66,617
reports naming it as manufacturer: 0.3% of all MAUDE reports; 6,462
reports, 12 months to August 2026: 5,501 in the 12 months before; 39.1%
classified as malfunction: 62.3% across all reports; 9.9%
classified as death, as reported: 0.9% across all reports

66,617 medical device reports received by FDA give Medtronic Ireland as the manufacturer of the device involved, 0.3% of the MAUDE database, from April 2000 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

6,462 reports arrived in the 12 months to August 2026, up 17% from 5,501 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 (50.9%), malfunction (39.1%) and death (9.9%). 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
Micra	Leadless pacemaker	6,727	524	8.4%
Resolute Onyx Rx	Coronary drug-eluting stent	5,797	88	8.7%
Resolute Integrity Rx	Coronary drug-eluting stent	4,698	70	7.9%
Micra AV	Leadless pacemaker	4,198	277	7.9%
Micra AV2	Leadless pacemaker	3,059	1,502	5.7%
Endeavor Sprint Rx	Coronary drug-eluting stent	2,399	0	28.5%
Endurant	System, endovascular graft, aortic aneurysm treatment	1,732	0	14.7%
Endurant Iis Bifurcated Stent Graft	System, endovascular graft, aortic aneurysm treatment	1,706	121	11.6%
Valiant Captivia - FF	System, endovascular graft, aortic aneurysm treatment	1,524	95	15.1%
Endeavor Resolute Rx	Coronary drug-eluting stent	1,460	0	0.3%
Endurant Stent Graft	System, endovascular graft, aortic aneurysm treatment	1,429	56	10%
Valiant Navion	System, endovascular graft, aortic aneurysm treatment	1,141	40	17.4%
Onyx Frontier	Coronary drug-eluting stent	1,010	250	4.3%
Vena Seal Closure System	Agent, occluding, vascular, permanent	1,008	91	1.3%
Evolut Fx Dcs	Aortic valve, prosthesis, percutaneously delivered	979	860	10.8%
In Pact Admiral Paclitaxel-Eluting Pta Balloon Catheter	Drug-eluting peripheral transluminal angioplasty catheter	899	104	6.5%
Micra VR2	Leadless pacemaker	895	425	5.2%
Deflect	Catheter, percutaneous	886	247	0.1%
FlexCath Contour Steerable Sheath	Catheter, steerable	845	399	1.5%
Endurant Abdominal Stent Graft System	System, endovascular graft, aortic aneurysm treatment	746	0	12.9%
Endeavor Sprint Rx Coronary Stent System	Coronary drug-eluting stent	741	0	17.4%
Endo Anchor System - Heli-Fx Aaa	Endovascular suturing system	668	50	10.4%
In Pact Av Access	Drug-eluting peripheral transluminal angioplasty catheter	667	94	1.2%
Endurant Bifurcated Stent Graft	System, endovascular graft, aortic aneurysm treatment	580	13	13.8%
Valiant Captivia - CW	System, endovascular graft, aortic aneurysm treatment	571	25	16.7%
Hawkone 6fr	Catheter, peripheral, atherectomy	502	30	0%
Integrity Rx	Stent, coronary	493	0	8.4%
Valiant Captivia	System, endovascular graft, aortic aneurysm treatment	476	6	21.6%
Valiant Stent Graft	System, endovascular graft, aortic aneurysm treatment	472	31	11.6%
Endurant Iliac Stent Graft	System, endovascular graft, aortic aneurysm treatment	466	11	13%

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	22,015	33%
NIQ	Coronary drug-eluting stent	17,548	26.3%
PNJ	Leadless pacemaker	14,005	21%
DQY	Catheter, percutaneous	2,521	3.8%
ONU	Drug-eluting peripheral transluminal angioplasty catheter	1,625	2.4%
DYB	Introducer, catheter	1,171	1.8%
PJQ	Agent, occluding, vascular, permanent	1,165	1.7%
NPT	Aortic valve, prosthesis, percutaneously delivered	1,141	1.7%
MAF	Stent, coronary	928	1.4%
MCW	Catheter, peripheral, atherectomy	873	1.3%

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

Death9.9%6,609

Injury50.9%33,937

Malfunction39.1%26,051

Other0%6

Not given0%14

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

Questions about Medtronic Ireland reports

How many FDA device reports name Medtronic Ireland as manufacturer?

66,617 reports through August 2026, 6,462 of them in the latest 12 months.

Which of its brands appear most often?

Micra (6,727), Resolute Onyx Rx (5,797), Resolute Integrity Rx (4,698), Micra AV (4,198) and Micra AV2 (3,059).

Which device types does it report on?

system, endovascular graft, aortic aneurysm treatment (33%), coronary drug-eluting stent (26.3%), leadless pacemaker (21%) and catheter, percutaneous (3.8%).

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.