Device manufacturer, as written on reports

Medtronic Heart Valves Division: medical device reports filed with FDA

43,598 reports name it as the manufacturer of the device involved, 2014–2026.

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.

43,598
reports naming it as manufacturer: 0.2% of all MAUDE reports; 1,447
reports, 12 months to August 2026: 8,067 in the 12 months before; 11.9%
classified as malfunction: 62.3% across all reports; 8.5%
classified as death, as reported: 0.9% across all reports

43,598 medical device reports received by FDA give Medtronic Heart Valves Division as the manufacturer of the device involved, 0.2% of the MAUDE database, from February 2014 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

1,447 reports arrived in the 12 months to August 2026, down 82% from 8,067 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 (79.6%), malfunction (11.9%) and death (8.5%). 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 R Transcatheter Aortic Valve	Aortic valve, prosthesis, percutaneously delivered	5,814	521	9.6%
Evolut Pro Plus Valve	Aortic valve, prosthesis, percutaneously delivered	4,999	780	12.8%
Evolut Fx Valve	Aortic valve, prosthesis, percutaneously delivered	4,266	851	14.1%
Evolut Pro Transcatheter Aortic Valve	Aortic valve, prosthesis, percutaneously delivered	3,195	422	11%
Mosaic Aortic Bioprosthetic Heart Valve	Replacement heart-valve	2,577	405	2.8%
Mosaic	Replacement heart-valve	1,873	131	0.5%
Freestyle Aortic Root Bioprosthesis	Heart-valve, non-allograft tissue	1,830	202	6%
Evolut Fx Dcs	Aortic valve, prosthesis, percutaneously delivered	1,573	860	10.8%
Corevalve Transcatheter Aortic Valve	Aortic valve, prosthesis, percutaneously delivered	1,562	60	9.6%
Mosaic Mitral Bioprosthetic Heart Valve	Heart-valve, non-allograft tissue	1,180	154	6.4%
Evolut Pro Plus Dcs	Aortic valve, prosthesis, percutaneously delivered	948	76	13.8%
Enveo Pro Delivery System	Aortic valve, prosthesis, percutaneously delivered	946	27	9.6%
Evolut Fx Plus Valve	Aortic valve, prosthesis, percutaneously delivered	941	2,316	8.9%
Enveo R Delivery System	Aortic valve, prosthesis, percutaneously delivered	926	6	9.9%
Medtronic Transcatheter Valve	Aortic valve, prosthesis, percutaneously delivered	888	262	7.2%
CG Future Band	Ring, annuloplasty	777	131	1.1%
Corevalve 31mm Aortic Valve	Aortic valve, prosthesis, percutaneously delivered	664	0	4.1%
Contegra	Pulmonic valved conduit	592	43	2.4%
Melody Transcatheter Pulmonary Valve	Pulmonary valve prosthesis percutaneously delivered	537	106	5.7%
Corevalve 29mm Aortic Valve	Aortic valve, prosthesis, percutaneously delivered	446	0	6.4%
Avalus Aortic Tissue Valve	Heart-valve, non-allograft tissue	365	133	11%
Hancock	Heart-valve, non-allograft tissue	352	22	1.5%
Corevalve	Aortic valve, prosthesis, percutaneously delivered	301	0	9.1%
Freestyle	Glucose dehydrogenase, glucose	274	26	0.1%
Corevalve 26mm Aortic Valve	Aortic valve, prosthesis, percutaneously delivered	243	0	7.5%
Mosaic Porcine Heart Valve	Replacement heart-valve	240	11	0.6%
Accutrak Delivery Catheter System	Aortic valve, prosthesis, percutaneously delivered	214	0	8%
Melody Transcather Pulmonary Valve	Pulmonary valve prosthesis percutaneously delivered	214	0	5.5%
Corevalve Revalving System	Aortic valve, prosthesis, percutaneously delivered	186	0	5.2%
Harmony Transcatheter Pulmonary Valve	Pulmonary valve prosthesis percutaneously delivered	181	90	4.1%

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	28,320	65%
DYE	Replacement heart-valve	5,611	12.9%
LWR	Heart-valve, non-allograft tissue	4,763	10.9%
KRH	Ring, annuloplasty	2,466	5.7%
NPV	Pulmonary valve prosthesis percutaneously delivered	1,197	2.7%
MWH	Pulmonic valved conduit	812	1.9%
LWQ	Heart-valve, mechanical	205	0.5%
DQX	Wire, guide, catheter	188	0.4%
LDF	Electrode, pacemaker, temporary	50	0.1%
DWS	Instruments, surgical, cardiovascular	11	0%

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

Death8.5%3,693

Injury79.6%34,703

Malfunction11.9%5,197

Other0%2

Not given0%3

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

Questions about Medtronic Heart Valves Division reports

How many FDA device reports name Medtronic Heart Valves Division as manufacturer?

43,598 reports through August 2026, 1,447 of them in the latest 12 months.

Which of its brands appear most often?

Evolut R Transcatheter Aortic Valve (5,814), Evolut Pro Plus Valve (4,999), Evolut Fx Valve (4,266), Evolut Pro Transcatheter Aortic Valve (3,195) and Mosaic Aortic Bioprosthetic Heart Valve (2,577).

Which device types does it report on?

aortic valve, prosthesis, percutaneously delivered (65%), replacement heart-valve (12.9%), heart-valve, non-allograft tissue (10.9%) and ring, annuloplasty (5.7%).

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.