Device manufacturer, as written on reports

Covidien Irvine: medical device reports filed with FDA

3,837 reports name it as the manufacturer of the device involved, 2013–2019.

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.

3,837
reports naming it as manufacturer: 0% of all MAUDE reports; 0
reports, 12 months to August 2026: 0 in the 12 months before; 48.3%
classified as malfunction: 62.3% across all reports; 7%
classified as death, as reported: 0.9% across all reports

3,837 medical device reports received by FDA give Covidien Irvine as the manufacturer of the device involved, 0% of the MAUDE database, from March 2013 to July 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 malfunction (48.3%), injury (44.7%) and death (7%). 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
Pipeline Embolization Device	Intracranial aneurysm flow diverter	547	0	10.3%
Pipeline Flex Embolization Device	Intracranial aneurysm flow diverter	494	31	7.8%
Onyx	Agent, injectable, embolic	346	69	13.4%
Onyx Avm	Agent, injectable, embolic	238	27	4.9%
Pipeline Flex	Intracranial aneurysm flow diverter	210	391	1.4%
Marathon	Catheter, continuous flush	87	66	5.9%
Apollo	Agent, injectable, embolic	76	141	1.8%
Axium Prime Brpl 3d	Device, vascular, for promoting embolization	76	135	1%
Axium 3d	Device, vascular, for promoting embolization	53	48	1.6%
Pipeline	Intracranial aneurysm flow diverter	51	61	21.8%
Solitaire Fr	Catheter, thrombus retriever	50	93	12.3%
Marksman	Catheter, continuous flush	47	77	6.7%
Axium	Device, neurovascular embolization	42	14	13.1%
Axium Helix	Device, vascular, for promoting embolization	42	24	3%
Pipeline Flex W/Shield Technology	Intracranial aneurysm flow diverter	41	922	2.2%
Axium Prime Brpl Hlx	Device, vascular, for promoting embolization	39	106	1%
Echelon	Catheter, continuous flush	37	584	3.2%
Concerto Nylon	Device, vascular, for promoting embolization	33	160	2.6%
Hawkone 6fr	Catheter, peripheral, atherectomy	13	30	0%
Axium Framing Coil	Device, vascular, for promoting embolization	12	57	0%
Axium Prime Bare Pl 3d	Device, vascular, for promoting embolization	7	27	0%
Concerto Pgla Hlx	Device, vascular, for promoting embolization	2	54	0.8%
Cathera	Catheter, continuous flush	1	0	7.3%

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
OUT	Intracranial aneurysm flow diverter	1,396	36.4%
MFE	Agent, injectable, embolic	721	18.8%
KRD	Device, vascular, for promoting embolization	687	17.9%
NRY	Catheter, thrombus retriever	363	9.5%
KRA	Catheter, continuous flush	356	9.3%
MCW	Catheter, peripheral, atherectomy	115	3%
DQY	Catheter, percutaneous	73	1.9%
MJN	Catheter, intravascular occluding, temporary	47	1.2%
DQX	Wire, guide, catheter	37	1%
HCG	Device, neurovascular embolization	18	0.5%

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

Death7%269

Injury44.7%1,714

Malfunction48.3%1,854

Other0%0

Not given0%0

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

Questions about Covidien Irvine reports

How many FDA device reports name Covidien Irvine as manufacturer?

3,837 reports through August 2026, 0 of them in the latest 12 months.

Which of its brands appear most often?

Pipeline Embolization Device (547), Pipeline Flex Embolization Device (494), Onyx (346), Onyx Avm (238) and Pipeline Flex (210).

Which device types does it report on?

intracranial aneurysm flow diverter (36.4%), agent, injectable, embolic (18.8%), device, vascular, for promoting embolization (17.9%) and catheter, thrombus retriever (9.5%).

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.