Device manufacturer, as written on reports

Medtronic Heart Valve Division: medical device reports filed with FDA

1,864 reports name it as the manufacturer of the device involved, 2014–2022.

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.

1,864
reports naming it as manufacturer: 0% of all MAUDE reports; 0
reports, 12 months to August 2026: 0 in the 12 months before; 0.4%
classified as malfunction: 62.3% across all reports; 2.6%
classified as death, as reported: 0.9% across all reports

1,864 medical device reports received by FDA give Medtronic Heart Valve Division as the manufacturer of the device involved, 0% of the MAUDE database, from February 2014 to March 2022. 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 injury (97%), death (2.6%) and malfunction (0.4%). 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
Mosaic	Replacement heart-valve	260	131	0.5%
Freestyle Aortic Root Bioprosthesis	Heart-valve, non-allograft tissue	230	202	6%
Mosaic Aortic Bioprosthetic Heart Valve	Replacement heart-valve	229	405	2.8%
Mosaic Mitral Bioprosthetic Heart Valve	Heart-valve, non-allograft tissue	164	154	6.4%
Contegra	Pulmonic valved conduit	143	43	2.4%
CG Future Band	Ring, annuloplasty	142	131	1.1%
Hancock	Heart-valve, non-allograft tissue	74	22	1.5%
Freestyle	Glucose dehydrogenase, glucose	46	26	0.1%
Mosaic Porcine Heart Valve	Replacement heart-valve	44	11	0.6%
Avalus Aortic Tissue Valve	Heart-valve, non-allograft tissue	33	133	11%
Simulus Fully Flexible Annuloplasty Band	Ring, annuloplasty	32	13	0.9%
Aortic Ap	Heart-valve, mechanical	31	44	2.7%
Simulus Semi-Rigid Annulopasty Ring	Ring, annuloplasty	29	13	0.4%
Open Pivot Mechanical Heart Valve	Heart-valve, mechanical	20	12	5%
Melody Transcather Pulmonary	Pulmonary valve prosthesis percutaneously delivered	5	0	4%
Corevalve	Aortic valve, prosthesis, percutaneously delivered	3	0	9.1%
Corevalve 31mm Aortic Valve	Aortic valve, prosthesis, percutaneously delivered	3	0	4.1%
Evolut Pro Plus Valve	Aortic valve, prosthesis, percutaneously delivered	3	780	12.8%
Accutrak Delivery Catheter System	Aortic valve, prosthesis, percutaneously delivered	2	0	8%
Corevalve 29mm Aortic Valve	Aortic valve, prosthesis, percutaneously delivered	2	0	6.4%
Corevalve Revalving System	Aortic valve, prosthesis, percutaneously delivered	1	0	5.2%
Evolut Pro Transcatheter Aortic Valve	Aortic valve, prosthesis, percutaneously delivered	1	422	11%
Evolut R Transcatheter Aortic Valve	Aortic valve, prosthesis, percutaneously delivered	1	521	9.6%
Melody Transcatheter Pulmonary Valve	Pulmonary valve prosthesis percutaneously delivered	1	106	5.7%

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
LWR	Heart-valve, non-allograft tissue	867	46.5%
KRH	Ring, annuloplasty	392	21%
DYE	Replacement heart-valve	351	18.8%
MWH	Pulmonic valved conduit	144	7.7%
LWQ	Heart-valve, mechanical	79	4.2%
NPT	Aortic valve, prosthesis, percutaneously delivered	21	1.1%
NPV	Pulmonary valve prosthesis percutaneously delivered	6	0.3%
LDF	Electrode, pacemaker, temporary	5	0.3%

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

Death2.6%48

Injury97%1,809

Malfunction0.4%7

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 Heart Valve Division reports

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

1,864 reports through August 2026, 0 of them in the latest 12 months.

Which of its brands appear most often?

Mosaic (260), Freestyle Aortic Root Bioprosthesis (230), Mosaic Aortic Bioprosthetic Heart Valve (229), Mosaic Mitral Bioprosthetic Heart Valve (164) and Contegra (143).

Which device types does it report on?

heart-valve, non-allograft tissue (46.5%), ring, annuloplasty (21%), replacement heart-valve (18.8%) and pulmonic valved conduit (7.7%).

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.