Device manufacturer, as written on reports

Medtronic Mexico: medical device reports filed with FDA

6,363 reports name it as the manufacturer of the device involved, 2011–2026.

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.

6,363
reports naming it as manufacturer: 0% of all MAUDE reports; 33
reports, 12 months to August 2026: 940 in the 12 months before; 72.6%
classified as malfunction: 62.3% across all reports; 2.1%
classified as death, as reported: 0.9% across all reports

6,363 medical device reports received by FDA give Medtronic Mexico as the manufacturer of the device involved, 0% of the MAUDE database, from March 2011 to January 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

33 reports arrived in the 12 months to August 2026, down 96% from 940 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 (72.6%), injury (25.2%) and death (2.1%). 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
Euphora Rx	Catheters, transluminal coronary angioplasty, percutaneous	465	43	1.7%
Sprinter Legend Rx	Catheters, transluminal coronary angioplasty, percutaneous	423	26	1.8%
Nc Euphora Rx	Catheters, transluminal coronary angioplasty, percutaneous	419	34	3.9%
Custom Tubing Pack	Tubing, pump, cardiopulmonary bypass	404	353	1.1%
Achieve Mapping Catheter	Catheter, electrode recording, or probe, electrode recording	342	0	4.7%
Nc Sprinter Rx	Catheters, transluminal coronary angioplasty, percutaneous	278	41	1.1%
Duet	Device, monitoring, intracranial pressure	236	10	0%
Achieve Mapping Catheter - 20 mm	Catheter, electrode recording, or probe, electrode recording	186	82	3.1%
Becker	Device, monitoring, intracranial pressure	170	18	0%
Admiral Xtreme Otw	Catheter, angioplasty, peripheral, transluminal	144	13	1%
Amphirion Deep Otw	Catheter, percutaneous	144	16	0%
Pacific Xtreme	Catheter, angioplasty, peripheral, transluminal	143	0	4%
Exacta External Drainage And Monitoring System	Device, monitoring, intracranial pressure	134	0	0%
Concerto Nylon	Device, vascular, for promoting embolization	130	160	2.6%
Kyphon Xpander Inflatable Bone Tamp	Arthroscope	125	22	0%
Avalus Aortic Tissue Valve	Heart-valve, non-allograft tissue	124	133	11%
Exacta	Device, monitoring, intracranial pressure	95	37	2%
EDM Lumbar Drainage Kit	Device, monitoring, intracranial pressure	87	54	0.5%
autoLog Wash Kit	Apparatus, autotransfusion	83	46	0.6%
Admiral Xtreme	Catheter, angioplasty, peripheral, transluminal	79	0	4.7%
Pacific Plus	Catheter, angioplasty, peripheral, transluminal	79	9	6.7%
Axium Prime Brpl 3d	Device, vascular, for promoting embolization	77	135	1%
Axium 3d	Device, vascular, for promoting embolization	52	48	1.6%
Axium Prime Brpl Hlx	Device, vascular, for promoting embolization	50	106	1%
Cathera	Catheter, continuous flush	42	0	7.3%
CG Future Band	Ring, annuloplasty	35	131	1.1%
Axium Helix	Device, vascular, for promoting embolization	28	24	3%
Launcher 6F Guide Catheter	Catheter, percutaneous	25	25	4.6%
Simuplus	Ring, annuloplasty	23	49	1.2%
Amphirion Deep Pta Balloon Catheter	Catheter, percutaneous	19	0	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
LOX	Catheters, transluminal coronary angioplasty, percutaneous	1,731	27.2%
GWM	Device, monitoring, intracranial pressure	1,006	15.8%
DRF	Catheter, electrode recording, or probe, electrode recording	553	8.7%
LIT	Catheter, angioplasty, peripheral, transluminal	486	7.6%
DWE	Tubing, pump, cardiopulmonary bypass	435	6.8%
KRD	Device, vascular, for promoting embolization	406	6.4%
HRX	Arthroscope	359	5.6%
DWF	Catheter, cannula and tubing, vascular, cardiopulmonary bypass	281	4.4%
KRH	Ring, annuloplasty	232	3.6%
DQY	Catheter, percutaneous	224	3.5%

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

Death2.1%136

Injury25.2%1,605

Malfunction72.6%4,622

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 Medtronic Mexico reports

How many FDA device reports name Medtronic Mexico as manufacturer?

6,363 reports through August 2026, 33 of them in the latest 12 months.

Which of its brands appear most often?

Euphora Rx (465), Sprinter Legend Rx (423), Nc Euphora Rx (419), Custom Tubing Pack (404) and Achieve Mapping Catheter (342).

Which device types does it report on?

catheters, transluminal coronary angioplasty, percutaneous (27.2%), device, monitoring, intracranial pressure (15.8%), catheter, electrode recording, or probe, electrode recording (8.7%) and catheter, angioplasty, peripheral, transluminal (7.6%).

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.