Device manufacturer, as written on reports

Thoratec Switzerland: medical device reports filed with FDA

2,669 reports name it as the manufacturer of the device involved, 2013–2026.

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.

2,669
reports naming it as manufacturer: 0% of all MAUDE reports; 337
reports, 12 months to August 2026: 342 in the 12 months before; 67.2%
classified as malfunction: 62.3% across all reports; 3.7%
classified as death, as reported: 0.9% across all reports

2,669 medical device reports received by FDA give Thoratec Switzerland as the manufacturer of the device involved, 0% of the MAUDE database, from March 2013 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

337 reports arrived in the 12 months to August 2026, close to the 342 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 malfunction (67.2%), injury (29.1%) and death (3.7%). 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
CentriMag Motor, US	Pump, blood, cardiopulmonary bypass, non-roller type	652	84	0.8%
CentriMag 2nd Generation Primary Console	Control, pump speed, cardiopulmonary bypass	649	120	0.3%
CentriMag Motor, OUS	Pump, blood, cardiopulmonary bypass, non-roller type	338	39	1.4%
CentriMag Blood Pump	Pump, blood, cardiopulmonary bypass, non-roller type	265	39	17.2%
HeartMate 3 LVAS Implant Kit	Ventricular (assist) bypass	1	626	38%

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
DWA	Control, pump speed, cardiopulmonary bypass	1,232	46.2%
KFM	Pump, blood, cardiopulmonary bypass, non-roller type	1,055	39.5%
QNR	Blood pump for ecmo, long-term (> 6 hours) use	367	13.8%
DSQ	Ventricular (assist) bypass	26	1%
DWF	Catheter, cannula and tubing, vascular, cardiopulmonary bypass	17	0.6%
DTZ	Oxygenator, cardiopulmonary bypass	6	0.2%

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

Death3.7%98

Injury29.1%777

Malfunction67.2%1,794

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 Thoratec Switzerland reports

How many FDA device reports name Thoratec Switzerland as manufacturer?

2,669 reports through August 2026, 337 of them in the latest 12 months.

Which of its brands appear most often?

CentriMag Motor, US (652), CentriMag 2nd Generation Primary Console (649), CentriMag Motor, OUS (338), CentriMag Blood Pump (265) and HeartMate 3 LVAS Implant Kit (1).

Which device types does it report on?

control, pump speed, cardiopulmonary bypass (46.2%), pump, blood, cardiopulmonary bypass, non-roller type (39.5%), blood pump for ecmo, long-term (> 6 hours) use (13.8%) and ventricular (assist) bypass (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.