Device manufacturer, as written on reports

Thoratec: medical device reports filed with FDA

78,106 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.

78,106
reports naming it as manufacturer: 0.3% of all MAUDE reports; 7,189
reports, 12 months to August 2026: 7,763 in the 12 months before; 32.9%
classified as malfunction: 62.3% across all reports; 20%
classified as death, as reported: 0.9% across all reports

78,106 medical device reports received by FDA give Thoratec as the manufacturer of the device involved, 0.3% of the MAUDE database, from February 2001 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

7,189 reports arrived in the 12 months to August 2026, close to the 7,763 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 (47.1%), malfunction (32.9%) and death (20%). 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
HeartMate 3 LVAS Implant Kit	Ventricular (assist) bypass	13,403	626	38%
Thoratec HeartMate 3 LVAS Implant Kit	Ventricular (assist) bypass	8,106	3,008	29.7%
HeartMate 3 Left Ventricular Assist System	Ventricular (assist) bypass	5,842	122	18.6%
Thoratec HeartMate 3 System Controller	Ventricular (assist) bypass	3,579	1,387	0%
HeartMate 3 System Controller	Ventricular (assist) bypass	3,446	247	0.3%
Heartmate Mobile Power Unit Na	Ventricular (assist) bypass	2,084	4	0.1%
Heartmate Mobile Power Unit N/A	Ventricular (assist) bypass	1,227	519	0%
Thoratec Heartmate Lvas Implant Kit With Sealed Grafts	Ventricular (assist) bypass	899	277	21.6%
HeartMate 3 VAD Modular Cable	Ventricular (assist) bypass	745	95	0.1%
Thoratec HeartMate 3 VAD Modular Cable	Ventricular (assist) bypass	655	251	0%
HeartMate Mobile Power Unit, EU	Ventricular (assist) bypass	645	67	0.2%
Heartmate Xve Lvas	Ventricular (assist) bypass	637	0	12.7%
Thoratec Heartmate System Monitor	Ventricular (assist) bypass	298	9	0%
Heartmate Power Module	Ventricular (assist) bypass	254	6	1.1%
Heartmate Power Module Eu	Ventricular (assist) bypass	243	30	0%
Thoratec Ventricular Assist Device Vad System	Ventricular (assist) bypass	239	0	11.3%
Heartmate Power Module N/A	Ventricular (assist) bypass	225	74	0%
Heartmate	Ventricular (assist) bypass	198	12	3.2%
Heartmate 3 Left Ventricular Assist System Europe	Ventricular (assist) bypass	160	0	11.3%
HeartMate 3	Ventricular (assist) bypass	134	67	2.5%
CentriMag 2nd Generation Primary Console	Control, pump speed, cardiopulmonary bypass	13	120	0.3%
Freestyle	Glucose dehydrogenase, glucose	1	26	0.1%

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
DSQ	Ventricular (assist) bypass	77,841	99.7%
DSY	Prosthesis, vascular graft, of 6mm and greater diameter	76	0.1%
DWA	Control, pump speed, cardiopulmonary bypass	75	0.1%
KFM	Pump, blood, cardiopulmonary bypass, non-roller type	45	0.1%
DTZ	Oxygenator, cardiopulmonary bypass	27	0%
QNR	Blood pump for ecmo, long-term (> 6 hours) use	26	0%
DWF	Catheter, cannula and tubing, vascular, cardiopulmonary bypass	8	0%
DWS	Instruments, surgical, cardiovascular	3	0%
LOZ	Artificial heart	2	0%
NBE	Sealant, polymerizing	2	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

Death20%15,583

Injury47.1%36,760

Malfunction32.9%25,692

Other0%25

Not given0.1%46

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

Questions about Thoratec reports

How many FDA device reports name Thoratec as manufacturer?

78,106 reports through August 2026, 7,189 of them in the latest 12 months.

Which of its brands appear most often?

HeartMate 3 LVAS Implant Kit (13,403), Thoratec HeartMate 3 LVAS Implant Kit (8,106), HeartMate 3 Left Ventricular Assist System (5,842), Thoratec HeartMate 3 System Controller (3,579) and HeartMate 3 System Controller (3,446).

Which device types does it report on?

ventricular (assist) bypass (99.7%), prosthesis, vascular graft, of 6mm and greater diameter (0.1%), control, pump speed, cardiopulmonary bypass (0.1%) and pump, blood, cardiopulmonary bypass, non-roller type (0.1%).

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.