Device manufacturer, as written on reports

Edwards Lifesciences: medical device reports filed with FDA

96,334 reports name it as the manufacturer of the device involved, 2001–2026.

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.

96,334
reports naming it as manufacturer: 0.4% of all MAUDE reports; 10,653
reports, 12 months to August 2026: 9,737 in the 12 months before; 12.9%
classified as malfunction: 62.3% across all reports; 8.1%
classified as death, as reported: 0.9% across all reports

96,334 medical device reports received by FDA give Edwards Lifesciences as the manufacturer of the device involved, 0.4% of the MAUDE database, from January 2001 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

10,653 reports arrived in the 12 months to August 2026, close to the 9,737 of 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 (78.1%), malfunction (12.9%) and death (8.1%). 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
Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis	Replacement heart-valve	8,150	495	2.6%
Edwards SAPIEN 3 Transcatheter Heart valve	Aortic valve, prosthesis, percutaneously delivered	8,078	668	9.2%
Carpentier-Edwards PERIMOUNT Magna Mitral Ease Pericardial Bioprosthesis	Replacement heart-valve	3,888	233	1%
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve	Aortic valve, prosthesis, percutaneously delivered	3,720	714	14%
Carpentier-Edwards Perimount Magna Pericardial Bioprosthesis	Replacement heart-valve	3,485	53	7.7%
Carpentier-Edwards Perimount Rsr Pericardial Bioprosthesis	Replacement heart-valve	3,102	13	3.3%
Edwards COMMANDER DELIVERY SYSTEM	Aortic valve, prosthesis, percutaneously delivered	3,087	368	12.3%
Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve	Aortic valve, prosthesis, percutaneously delivered	2,876	1,128	11.6%
Carpentier-Edwards PERIMOUNT Plus Pericardial Bioprosthesis	Replacement heart-valve	2,794	18	8.7%
Edwards SAPIEN XT Transcatheter Heart Valve	Aortic valve, prosthesis, percutaneously delivered	2,158	48	7.6%
SAPIEN 3 Transcatheter Heart Valve	Aortic valve, prosthesis, percutaneously delivered	2,143	419	6%
Edwards INSPIRIS RESILIA Aortic Valve	Heart-valve, non-allograft tissue	2,018	599	0.8%
Edwards Pascal Precision	Mitral valve repair devices	1,905	1,395	16.4%
Edwards Sapien Transcatheter Heart Valve	Aortic valve, prosthesis, percutaneously delivered	1,858	7	14.3%
Carpentier-Edwards Perimount Theon Pericardial Bioprosthesis	Replacement heart-valve	1,606	46	3.9%
Commander Delivery System	Aortic valve, prosthesis, percutaneously delivered	1,399	306	10.6%
Carpentier-Edwards Physio Annuloplasty Ring	Ring, annuloplasty	1,368	0	7.8%
Edwards eSheath Introducer Set	Aortic valve, prosthesis, percutaneously delivered	1,338	15	9.7%
Carpentier-Edwards Perimount Magna Aortic Bioprosthesis	Heart-valve, non-allograft tissue	1,228	11	27.1%
Edwards Sapien 3 Transcatheter	Aortic valve, prosthesis, percutaneously delivered	1,181	83	6.5%
Edwards eSheath+ Introducer Set	Introducer, catheter	971	393	3.1%
Cosgrove-Edwards Annuloplasty System	Ring, annuloplasty	894	2	6.6%
Carpentier-Edwards Perimount Magna Mitral Ease Pericardial Bioprostheses	Replacement heart-valve	799	0	3.8%
Carpentier-Edwards Perimount Aortic Pericardial Bioprosthesis	Replacement heart-valve	775	7	7.1%
Ni	Set, administration, for peritoneal dialysis, disposable	771	1,587	1.8%
Carpentier-Edwards Perimount Magna Mitral Pericardial Bioprosthesis	Replacement heart-valve	764	1	12.9%
Edwards SAPIEN 3 Transcatheter Heath Valve	Aortic valve, prosthesis, percutaneously delivered	744	67	14.9%
EDWARDS INTUITY ELITE Valve System	Heart-valve, non-allograft tissue	637	62	2.2%
Carpentier-Edwards Perimount Pericardial Bioprosthesis	Heart-valve, non-allograft tissue	625	1	10%
Edwards Expandable Introducer Sheath Set	Aortic valve, prosthesis, percutaneously delivered	559	0	2.9%

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	37,177	38.6%
DYE	Replacement heart-valve	30,436	31.6%
LWR	Heart-valve, non-allograft tissue	7,871	8.2%
KRH	Ring, annuloplasty	4,764	4.9%
DYB	Introducer, catheter	4,082	4.2%
NKM	Mitral valve repair devices	1,962	2%
NPU	Prosthesis, mitral valve, percutaneously delivered	1,909	2%
NPW	Percutaneously delivered prostheses and tricuspid valves	1,005	1%
DWF	Catheter, cannula and tubing, vascular, cardiopulmonary bypass	926	1%
DRS	Transducer, blood-pressure, extravascular	737	0.8%

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

Death8.1%7,780

Injury78.1%75,278

Malfunction12.9%12,438

Other0.7%635

Not given0.2%203

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

Questions about Edwards Lifesciences reports

How many FDA device reports name Edwards Lifesciences as manufacturer?

96,334 reports through August 2026, 10,653 of them in the latest 12 months.

Which of its brands appear most often?

Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis (8,150), Edwards SAPIEN 3 Transcatheter Heart valve (8,078), Carpentier-Edwards PERIMOUNT Magna Mitral Ease Pericardial Bioprosthesis (3,888), Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (3,720) and Carpentier-Edwards Perimount Magna Pericardial Bioprosthesis (3,485).

Which device types does it report on?

aortic valve, prosthesis, percutaneously delivered (38.6%), replacement heart-valve (31.6%), heart-valve, non-allograft tissue (8.2%) and ring, annuloplasty (4.9%).

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.