Device manufacturer, as written on reports

Edwards Lifesciences Pr: medical device reports filed with FDA

5,533 reports name it as the manufacturer of the device involved, 2007–2026.

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.

5,533
reports naming it as manufacturer: 0% of all MAUDE reports; 482
reports, 12 months to August 2026: 274 in the 12 months before; 92.6%
classified as malfunction: 62.3% across all reports; 0.9%
classified as death, as reported: 0.9% across all reports

5,533 medical device reports received by FDA give Edwards Lifesciences Pr as the manufacturer of the device involved, 0% of the MAUDE database, from July 2007 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

482 reports arrived in the 12 months to August 2026, up 76% from 274 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 (92.6%), injury (5.7%) and death (0.9%). 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
Fogarty Arterial Embolectomy Catheter	Catheter, embolectomy	952	37	0.2%
Fogarty Thru-Lumen Embolectomy Catheter	Catheter, embolectomy	397	76	0.7%
Swan-Ganz Bipolar Pacing Catheter For SVC Insertion	Electrode, pacemaker, temporary	269	14	0%
Swan-Ganz Bipolar Pacing Catheter For Femoral Insertion	Electrode, pacemaker, temporary	208	2	0.4%
Swan-Ganz Continuous Cardiac Output Catheter	Catheter, flow directed	154	0	0%
Swan-Ganz catheter	Catheter, flow directed	133	89	5.6%
Swan-Ganz Ccombo V	Catheter, flow directed	97	88	0.6%
Edwards eSheath Introducer Set	Aortic valve, prosthesis, percutaneously delivered	3	15	9.7%
TruWave Disposable Pressure Transducer	Transducer, blood-pressure, extravascular	3	67	0.5%

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
DYG	Catheter, flow directed	1,829	33.1%
DXE	Catheter, embolectomy	1,597	28.9%
DQE	Catheter, oximeter, fiber-optic	715	12.9%
LDF	Electrode, pacemaker, temporary	500	9%
DQY	Catheter, percutaneous	147	2.7%
DQO	Catheter, intravascular, diagnostic	122	2.2%
DYB	Introducer, catheter	117	2.1%
KRB	Probe, thermodilution	98	1.8%
KRA	Catheter, continuous flush	92	1.7%
DXC	Clamp, vascular	83	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

Death0.9%49

Injury5.7%318

Malfunction92.6%5,126

Other0.5%26

Not given0.3%14

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 Pr reports

How many FDA device reports name Edwards Lifesciences Pr as manufacturer?

5,533 reports through August 2026, 482 of them in the latest 12 months.

Which of its brands appear most often?

Fogarty Arterial Embolectomy Catheter (952), Fogarty Thru-Lumen Embolectomy Catheter (397), Swan-Ganz Bipolar Pacing Catheter For SVC Insertion (269), Swan-Ganz Bipolar Pacing Catheter For Femoral Insertion (208) and Swan-Ganz Continuous Cardiac Output Catheter (154).

Which device types does it report on?

catheter, flow directed (33.1%), catheter, embolectomy (28.9%), catheter, oximeter, fiber-optic (12.9%) and electrode, pacemaker, temporary (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.