Devices › Ventricular (assist) bypass
Device brand name · Circulatory assist system
Heartware Ventricular Assist System: medical device reports filed with FDA
14,550 reports name it, 2012–2025. Manufacturer given most often on reports: Heartware. Product code DSQ.
- 14,550
- device reports naming the brand
- 0.1% of all MAUDE reports · about 1,072 a year
- 0
- reports, 12 months to August 2026
- 5 in the 12 months before
- 61%
- classified as malfunction
- 37% across the product code
- 6.9%
- classified as death, as reported
- 1,011 reports · not verified by FDA
14,550 medical device reports received by FDA name the brand "Heartware Ventricular Assist System" (circulatory assist system); the manufacturer given most often on reports is Heartware; received from December 2012 to June 2025. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, against 5 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 (61%), injury (31.9%) and death (6.9%); 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 battery problem (18.7%), connection problem (11.2%) and loose or intermittent connection (7.7%). The patient problems coded most often are thrombus, death and blood loss. 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 |
|---|---|---|---|
| Battery problema problem with the battery | 2,715 | 18.7% | 6.5% |
| Connection problema connection problem | 1,631 | 11.2% | 2.5% |
| Loose or intermittent connection | 1,114 | 7.7% | 0.9% |
| Power problem | 1,098 | 7.5% | 4.5% |
| Pumping problem | 1,017 | 7% | 6.1% |
| Premature discharge of battery | 702 | 4.8% | 0.5% |
| Obstruction of flow | 364 | 2.5% | 1.3% |
| Device contamination with chemical or other material | 347 | 2.4% | 0.3% |
| Device operates differently than expectedthe device behaved unexpectedly | 282 | 1.9% | 0.9% |
| Material integrity problema problem with the device material | 259 | 1.8% | 1.9% |
| Device displays incorrect message | 210 | 1.4% | 0.6% |
| Pumping stopped | 210 | 1.4% | 3.2% |
| No audible alarm | 205 | 1.4% | 0.4% |
| Device alarm system | 203 | 1.4% | 0.4% |
| Loss of powerthe device lost power | 163 | 1.1% | 0.4% |
| Contamination | 140 | 1% | 0.2% |
| No display/image | 124 | 0.9% | 0.2% |
| Electrical /electronic property probleman electrical or electronic problem | 102 | 0.7% | 1.9% |
| Protective measures problem | 92 | 0.6% | 0.1% |
| Failure to power up | 88 | 0.6% | 0.2% |
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 |
|---|---|---|
| Thrombus | 1,063 | 7.3% |
| Deaththe patient died; cause not stated by this term | 997 | 6.9% |
| Blood loss | 868 | 6% |
| Neurological deficit/dysfunction | 497 | 3.4% |
| Stroke/cva | 357 | 2.5% |
| Hemolysis | 354 | 2.4% |
| Sepsisa severe body-wide response to infection | 237 | 1.6% |
| Post operative wound infection | 170 | 1.2% |
| Heart failure | 163 | 1.1% |
| Dizzinesslight-headedness or unsteadiness | 161 | 1.1% |
| Anemialow red blood cells | 154 | 1.1% |
| Hemorrhage, cerebral | 154 | 1.1% |
| Renal failurekidney failure | 153 | 1.1% |
| Arrhythmia | 148 | 1% |
| Multiple organ dysfunction syndromeseveral organs failing | 135 | 0.9% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Heartware Ventricular Assist System | Product code DSQ | All MAUDE reports |
|---|---|---|---|
| Reports | 14,550 | 158,083 | 26,136,888 |
| Share of that pool | — | 9.2% | 0.1% |
| Classified as death, per 1,000 reports | 69 | 146 | 9 |
| Classified as injury | 31.9% | 48.3% | 36.2% |
| Classified as malfunction | 61% | 37% | 62.3% |
| Filed by the manufacturer | 99.2% | 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% |
| 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% |
| 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 Heartware Ventricular Assist System reports
How many FDA reports name Heartware Ventricular Assist System?
14,550 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (61%), injury (31.9%) and death (6.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
battery problem (18.7%), connection problem (11.2%), loose or intermittent connection (7.7%), power problem (7.5%) and pumping problem (7%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.2%) 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 Heartware Ventricular Assist System 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.