Device manufacturer, as written on reports

Micro Therapeutics Ev3: medical device reports filed with FDA

15,928 reports name it as the manufacturer of the device involved, 2016–2026.

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.

15,928
reports naming it as manufacturer: 0.1% of all MAUDE reports; 2,416
reports, 12 months to August 2026: 3,016 in the 12 months before; 65.4%
classified as malfunction: 62.3% across all reports; 7.6%
classified as death, as reported: 0.9% across all reports

15,928 medical device reports received by FDA give Micro Therapeutics Ev3 as the manufacturer of the device involved, 0.1% of the MAUDE database, from July 2016 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

2,416 reports arrived in the 12 months to August 2026, down 20% from 3,016 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 (65.4%), injury (27%) and death (7.6%). 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 Flex W/Shield Technology	Intracranial aneurysm flow diverter	3,206	922	2.2%
Pipeline Flex	Intracranial aneurysm flow diverter	2,149	391	1.4%
Pipeline Vantage With Shield Technology	Intracranial aneurysm flow diverter	801	96	3%
Onyx	Agent, injectable, embolic	767	69	13.4%
Solitaire Fr4	Catheter, thrombus retriever	573	49	13.9%
Pipeline	Intracranial aneurysm flow diverter	555	61	21.8%
React catheter	Catheter, percutaneous	512	41	18.4%
Apollo	Agent, injectable, embolic	504	141	1.8%
Axium Prime Brpl 3d	Device, vascular, for promoting embolization	483	135	1%
Concerto Nylon	Device, vascular, for promoting embolization	471	160	2.6%
Echelon	Catheter, continuous flush	410	584	3.2%
Rebar	Catheter, continuous flush	399	108	9%
Solitaire Fr	Catheter, thrombus retriever	369	93	12.3%
Marathon	Catheter, continuous flush	354	66	5.9%
Axium Prime Brpl Hlx	Device, vascular, for promoting embolization	328	106	1%
Unknown Solitaire	Catheter, thrombus retriever	293	29	37.1%
Pipeline Flex Embolization Device	Intracranial aneurysm flow diverter	251	31	7.8%
Onyx Avm	Agent, injectable, embolic	231	27	4.9%
Cathera	Catheter, continuous flush	225	0	7.3%
Concerto Pgla Hlx	Device, vascular, for promoting embolization	223	54	0.8%
Axium 3d	Device, vascular, for promoting embolization	214	48	1.6%
Marksman	Catheter, continuous flush	213	77	6.7%
Axium	Device, neurovascular embolization	140	14	13.1%
Axium Framing Coil	Device, vascular, for promoting embolization	139	57	0%
Phenom Catheter	Catheter, percutaneous, neurovasculature	130	406	3.1%
Reflex Catheter	Catheter, percutaneous	127	29	25%
Rist	Catheter, percutaneous	99	53	3%
Axium Helix	Device, vascular, for promoting embolization	74	24	3%
Concerto	Implant, cochlear	47	199	2.7%
Axium Prime Bare Pl 3d	Device, vascular, for promoting embolization	43	27	0%

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	7,053	44.3%
KRD	Device, vascular, for promoting embolization	2,398	15.1%
KRA	Catheter, continuous flush	1,855	11.6%
MFE	Agent, injectable, embolic	1,551	9.7%
NRY	Catheter, thrombus retriever	1,495	9.4%
DQY	Catheter, percutaneous	863	5.4%
QJP	Catheter, percutaneous, neurovasculature	226	1.4%
MJN	Catheter, intravascular occluding, temporary	183	1.1%
HCG	Device, neurovascular embolization	157	1%
DQX	Wire, guide, catheter	95	0.6%

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

Death7.6%1,210

Injury27%4,304

Malfunction65.4%10,414

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 Micro Therapeutics Ev3 reports

How many FDA device reports name Micro Therapeutics Ev3 as manufacturer?

15,928 reports through August 2026, 2,416 of them in the latest 12 months.

Which of its brands appear most often?

Pipeline Flex W/Shield Technology (3,206), Pipeline Flex (2,149), Pipeline Vantage With Shield Technology (801), Onyx (767) and Solitaire Fr4 (573).

Which device types does it report on?

intracranial aneurysm flow diverter (44.3%), device, vascular, for promoting embolization (15.1%), catheter, continuous flush (11.6%) and agent, injectable, embolic (9.7%).

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.