Devices › Ventricular (assist) bypass
Device brand name · Ventricular assist bypass
Thoratec HeartMate 3 System Controller: medical device reports filed with FDA
3,591 reports name it, 2020–2026. Manufacturer given most often on reports: Thoratec. Product code DSQ.
- 3,591
- device reports naming the brand
- 0% of all MAUDE reports · about 599 a year
- 1,387
- reports, 12 months to August 2026
- 1,251 in the 12 months before
- 97.2%
- classified as malfunction
- 37% across the product code
- 0%
- classified as death, as reported
- 1 reports · not verified by FDA
3,591 medical device reports received by FDA name the brand "Thoratec HeartMate 3 System Controller" (ventricular assist bypass); the manufacturer given most often on reports is Thoratec; received from July 2020 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
1,387 reports arrived in the 12 months to August 2026, up 11% from 1,251 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 (97.2%), injury (2.6%) and other (0.1%); across all ventricular (assist) bypass reports (product code DSQ) death is recorded in 14.6% and malfunction in 37%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are electrical power problem (30.9%), disconnection (15.9%) and mechanical problem (14.1%). The patient problems coded most often are electric shock, syncope/fainting and loss of consciousness. 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."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 158,083 reports carrying product code DSQ. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Electrical power problem | 1,110 | 30.9% | 2.1% |
| Disconnection | 571 | 15.9% | 2% |
| Mechanical problema mechanical problem | 507 | 14.1% | 5.5% |
| Insufficient device problem information | 466 | 13% | 1.8% |
| Failure to charge | 392 | 10.9% | 0.4% |
| Electrical /electronic property probleman electrical or electronic problem | 371 | 10.3% | 1.9% |
| Material deformation | 252 | 7% | 0.9% |
| Communication or transmission problemthe device could not communicate or transmit | 225 | 6.3% | 0.8% |
| Improper or incorrect procedure or method | 222 | 6.2% | 0.5% |
| Complete loss of power | 213 | 5.9% | 1.7% |
| Display or visual feedback problem | 190 | 5.3% | 0.7% |
| Pumping stopped | 92 | 2.6% | 3.2% |
| Device difficult to setup or prepare | 85 | 2.4% | 0.6% |
| Overheating of device | 66 | 1.8% | 0.3% |
| Display difficult to read | 63 | 1.8% | 0.2% |
| No audible alarm | 48 | 1.3% | 0.4% |
| Unintended electrical shock | 48 | 1.3% | 0.1% |
| Product quality problem | 47 | 1.3% | 0% |
| No display/image | 43 | 1.2% | 0.2% |
| Low audible alarm | 41 | 1.1% | 0.1% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Electric shockan electric shock | 22 | 0.6% |
| Syncope/fainting | 12 | 0.3% |
| Loss of consciousnesspassing out | 7 | 0.2% |
| Chest painchest pain | 4 | 0.1% |
| Discomfortdiscomfort | 4 | 0.1% |
| Presyncope | 4 | 0.1% |
| Shockshock, a collapse of the circulation | 4 | 0.1% |
| Anxietyanxiety | 3 | 0.1% |
| Dyspneashortness of breath | 3 | 0.1% |
| Superficial (first degree) burn | 3 | 0.1% |
| Burn(s)a burn | 2 | 0.1% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 1 | 0% |
| Cardiac arrestthe heart stopped | 1 | 0% |
| Dizzinesslight-headedness or unsteadiness | 1 | 0% |
| Hemodynamic instability | 1 | 0% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Thoratec HeartMate 3 System Controller | Product code DSQ | All MAUDE reports |
|---|---|---|---|
| Reports | 3,591 | 158,083 | 26,136,888 |
| Share of that pool | — | 2.3% | 0% |
| Classified as death, per 1,000 reports | 0 | 146 | 9 |
| Classified as injury | 2.6% | 48.3% | 36.2% |
| Classified as malfunction | 97.2% | 37% | 62.3% |
| Filed by the manufacturer | 99.8% | 97% | 94.9% |
Shares are of reports, not 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."
Other brands with product code DSQ
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| HeartWare Ventricular Assist System - Pump | 36,450 | 1,304 | 13.4% |
| Heartware Ventricular Assist System | 14,550 | 0 | 6.9% |
| HeartMate 3 LVAS Implant Kit | 13,500 | 626 | 38% |
| Thoratec HeartMate 3 LVAS Implant Kit | 8,130 | 3,008 | 29.7% |
| HeartMate 3 Left Ventricular Assist System | 5,858 | 122 | 18.6% |
| HeartWare Ventricular Assist System - Controller 2.0 | 5,831 | 132 | 0.5% |
| HeartWare Ventricular Assist System - Battery | 5,010 | 47 | 0% |
| HeartMate 3 System Controller | 3,473 | 247 | 0.3% |
| HeartWare Ventricular Assist System - Driveline | 3,003 | 159 | 1.5% |
| HeartWare Ventricular Assist System - Pump/Driveline | 2,160 | 147 | 16.6% |
| Heartmate Mobile Power Unit Na | 2,096 | 4 | 0.1% |
| Heartware Ventricular Assist System-Pump | 1,424 | 0 | 19.9% |
| Heartware Ventricular Assist System- Pump | 1,306 | 0 | 35.4% |
| Heartmate Mobile Power Unit N/A | 1,234 | 519 | 0% |
| HeartWare Ventricular Assist System - Waist Pack | 917 | 17 | 0% |
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." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Thoratec HeartMate 3 System Controller reports
How many FDA reports name Thoratec HeartMate 3 System Controller?
3,591 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 1,387 in the latest 12 months.
What kinds of events are reported?
malfunction (97.2%), injury (2.6%) and other (0.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
electrical power problem (30.9%), disconnection (15.9%), mechanical problem (14.1%), insufficient device problem information (13%) and failure to charge (10.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.8%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Thoratec HeartMate 3 System Controller was at fault?
No. 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." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
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. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. 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.