Devices › Ventricular (assist) bypass
Device brand name · Ventricular assist bypass
HeartMate 3 LVAS Implant Kit: medical device reports filed with FDA
13,500 reports name it, 2019–2026. Manufacturer given most often on reports: Thoratec. Product code DSQ.
- 13,500
- device reports naming the brand
- 0.1% of all MAUDE reports · about 1,953 a year
- 626
- reports, 12 months to August 2026
- 887 in the 12 months before
- 8%
- classified as malfunction
- 37% across the product code
- 38%
- classified as death, as reported
- 5,131 reports · not verified by FDA
13,500 medical device reports received by FDA name the brand "HeartMate 3 LVAS Implant Kit" (ventricular assist bypass); the manufacturer given most often on reports is Thoratec; received from August 2019 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
626 reports arrived in the 12 months to August 2026, down 29% from 887 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 injury (54%), death (38%) and malfunction (8%); 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 infusion or flow problem (15.8%), mechanical problem (6.1%) and pumping stopped (3.2%). The patient problems coded most often are skin infection, heart failure/congestive heart failure and bacterial infection. 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 |
|---|---|---|---|
| Infusion or flow problema problem with flow or infusion | 2,129 | 15.8% | 4.9% |
| Mechanical problema mechanical problem | 829 | 6.1% | 5.5% |
| Pumping stopped | 428 | 3.2% | 3.2% |
| Material twisted/bent | 178 | 1.3% | 1% |
| Insufficient device problem information | 167 | 1.2% | 1.8% |
| Disconnection | 166 | 1.2% | 2% |
| Device difficult to setup or prepare | 160 | 1.2% | 0.6% |
| Decreased pump speed | 115 | 0.9% | 1.2% |
| Failure to align | 114 | 0.8% | 0.1% |
| Electrical /electronic property probleman electrical or electronic problem | 103 | 0.8% | 1.9% |
| Malposition of device | 89 | 0.7% | 0.4% |
| Fluid/blood leak | 88 | 0.7% | 0.2% |
| Improper or incorrect procedure or method | 88 | 0.7% | 0.5% |
| Communication or transmission problemthe device could not communicate or transmit | 83 | 0.6% | 0.8% |
| Obstruction of flow | 74 | 0.5% | 1.3% |
| Noise, audible | 63 | 0.5% | 0.4% |
| Electrostatic discharge | 59 | 0.4% | 0.1% |
| Electromagnetic interference | 57 | 0.4% | 0.1% |
| Electrical power problem | 49 | 0.4% | 2.1% |
| Off-label use | 35 | 0.3% | 0% |
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 |
|---|---|---|
| Skin infection | 1,525 | 11.3% |
| Heart failure/congestive heart failure | 1,414 | 10.5% |
| Bacterial infectiona bacterial infection | 1,203 | 8.9% |
| Hemorrhage/blood loss/bleeding | 1,163 | 8.6% |
| Thrombosis/thrombus | 780 | 5.8% |
| Stroke/cva | 627 | 4.6% |
| Deaththe patient died; cause not stated by this term | 605 | 4.5% |
| Gastrointestinal hemorrhage | 547 | 4.1% |
| Arrhythmia | 529 | 3.9% |
| Tachycardiafast heart rate | 467 | 3.5% |
| Sepsisa severe body-wide response to infection | 465 | 3.4% |
| Multiple organ dysfunction syndromeseveral organs failing | 417 | 3.1% |
| Dyspneashortness of breath | 398 | 2.9% |
| Renal failurekidney failure | 368 | 2.7% |
| Hemorrhagic stroke | 355 | 2.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | HeartMate 3 LVAS Implant Kit | Product code DSQ | All MAUDE reports |
|---|---|---|---|
| Reports | 13,500 | 158,083 | 26,136,888 |
| Share of that pool | — | 8.5% | 0.1% |
| Classified as death, per 1,000 reports | 380 | 146 | 9 |
| Classified as injury | 54% | 48.3% | 36.2% |
| Classified as malfunction | 8% | 37% | 62.3% |
| Filed by the manufacturer | 100% | 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% |
| 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% |
| Thoratec HeartMate 3 System Controller | 3,591 | 1,387 | 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 HeartMate 3 LVAS Implant Kit reports
How many FDA reports name HeartMate 3 LVAS Implant Kit?
13,500 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 626 in the latest 12 months.
What kinds of events are reported?
injury (54%), death (38%) and malfunction (8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
infusion or flow problem (15.8%), mechanical problem (6.1%), pumping stopped (3.2%), material twisted/bent (1.3%) and insufficient device problem information (1.2%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%) and voluntary reports (0%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that HeartMate 3 LVAS Implant Kit 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.