Device manufacturer, as written on reports

Medtronic Mexico S De R L De Cv: medical device reports filed with FDA

10,546 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.

10,546
reports naming it as manufacturer: 0% of all MAUDE reports; 7,998
reports, 12 months to August 2026: 1,636 in the 12 months before; 49.1%
classified as malfunction: 62.3% across all reports; 6%
classified as death, as reported: 0.9% across all reports

10,546 medical device reports received by FDA give Medtronic Mexico S De R L De Cv as the manufacturer of the device involved, 0% of the MAUDE database, from January 2016 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

7,998 reports arrived in the 12 months to August 2026, up 389% from 1,636 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 (49.1%), injury (44.9%) and death (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
Evolut Fx Plus Valve	Aortic valve, prosthesis, percutaneously delivered	2,504	2,316	8.9%
Evolut Fx Valve	Aortic valve, prosthesis, percutaneously delivered	997	851	14.1%
Achieve Mapping Catheter - 20 mm	Catheter, electrode recording, or probe, electrode recording	950	82	3.1%
Evolut Pro Plus Valve	Aortic valve, prosthesis, percutaneously delivered	835	780	12.8%
Evolut R Transcatheter Aortic Valve	Aortic valve, prosthesis, percutaneously delivered	567	521	9.6%
Evolut Pro Transcatheter Aortic Valve	Aortic valve, prosthesis, percutaneously delivered	447	422	11%
Phenom Catheter	Catheter, percutaneous, neurovasculature	421	406	3.1%
Custom Tubing Pack	Tubing, pump, cardiopulmonary bypass	367	353	1.1%
Medtronic Transcatheter Valve	Aortic valve, prosthesis, percutaneously delivered	262	262	7.2%
Concerto Nylon	Device, vascular, for promoting embolization	229	160	2.6%
Axium Prime Brpl 3d	Device, vascular, for promoting embolization	220	135	1%
Axium Prime Brpl Hlx	Device, vascular, for promoting embolization	179	106	1%
Avalus Aortic Tissue Valve	Heart-valve, non-allograft tissue	125	133	11%
Melody Transcatheter Pulmonary Valve	Pulmonary valve prosthesis percutaneously delivered	101	106	5.7%
EDM Lumbar Drainage Kit	Device, monitoring, intracranial pressure	99	54	0.5%
Harmony Transcatheter Pulmonary Valve	Pulmonary valve prosthesis percutaneously delivered	96	90	4.1%
Marksman	Catheter, continuous flush	94	77	6.7%
Axium Framing Coil	Device, vascular, for promoting embolization	88	57	0%
Exacta	Device, monitoring, intracranial pressure	86	37	2%
Axium 3d	Device, vascular, for promoting embolization	79	48	1.6%
CG Future Band	Ring, annuloplasty	73	131	1.1%
Becker	Device, monitoring, intracranial pressure	68	18	0%
Cathera	Catheter, continuous flush	68	0	7.3%
autoLog Wash Kit	Apparatus, autotransfusion	67	46	0.6%
Corevalve Transcatheter Aortic Valve	Aortic valve, prosthesis, percutaneously delivered	66	60	9.6%
Axium Helix	Device, vascular, for promoting embolization	34	24	3%
Simuplus	Ring, annuloplasty	33	49	1.2%
Euphora Rx	Catheters, transluminal coronary angioplasty, percutaneous	32	43	1.7%
Nc Sprinter Rx	Catheters, transluminal coronary angioplasty, percutaneous	27	41	1.1%
Kyphon Xpander Inflatable Bone Tamp	Arthroscope	24	22	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
NPT	Aortic valve, prosthesis, percutaneously delivered	5,695	54%
DRF	Catheter, electrode recording, or probe, electrode recording	943	8.9%
KRD	Device, vascular, for promoting embolization	887	8.4%
DWF	Catheter, cannula and tubing, vascular, cardiopulmonary bypass	561	5.3%
QJP	Catheter, percutaneous, neurovasculature	400	3.8%
GWM	Device, monitoring, intracranial pressure	363	3.4%
KRH	Ring, annuloplasty	293	2.8%
LOX	Catheters, transluminal coronary angioplasty, percutaneous	209	2%
NPV	Pulmonary valve prosthesis percutaneously delivered	203	1.9%
KRA	Catheter, continuous flush	154	1.5%

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

Death6%632

Injury44.9%4,732

Malfunction49.1%5,182

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 S De R L De Cv reports

How many FDA device reports name Medtronic Mexico S De R L De Cv as manufacturer?

10,546 reports through August 2026, 7,998 of them in the latest 12 months.

Which of its brands appear most often?

Evolut Fx Plus Valve (2,504), Evolut Fx Valve (997), Achieve Mapping Catheter - 20 mm (950), Evolut Pro Plus Valve (835) and Evolut R Transcatheter Aortic Valve (567).

Which device types does it report on?

aortic valve, prosthesis, percutaneously delivered (54%), catheter, electrode recording, or probe, electrode recording (8.9%), device, vascular, for promoting embolization (8.4%) and catheter, cannula and tubing, vascular, cardiopulmonary bypass (5.3%).

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.