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FDA product code DSQ · class 3 · Unknown
Ventricular (assist) bypass: medical device reports filed with FDA
158,083 reports carry this product code, 1992–2026; 30 brands with a page.
- 158,083
- reports with this product code
- 0.6% of all MAUDE reports
- 9,332
- reports, 12 months to August 2026
- 10,830 in the 12 months before
- 37%
- classified as malfunction
- 62.3% across all reports
- 14.6%
- classified as death, as reported
- 0.9% across all reports
Product code DSQ is FDA's classification for "Ventricular (assist) bypass" (unknown panel), a class 3 device. 158,083 medical device reports carry this product code, 0.6% of the MAUDE database, from January 1992 to August 2026.
9,332 reports arrived in the 12 months to August 2026, down 14% from 10,830 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 (48.3%), malfunction (37%) and death (14.6%). 30 brand names with a page on this site carry this code; the brands table is 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."
Brands with this product code
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."
Manufacturers named
| Manufacturer (as written on reports) | Reports | Share |
|---|---|---|
| Thoratec | 77,841 | 49.2% |
| Heartware | 77,289 | 48.9% |
| Abiomed | 251 | 0.2% |
| Syncardia Systems | 210 | 0.1% |
| Abbott | 124 | 0.1% |
| Thoratec Switzerland | 26 | 0% |
| Abbott Laboratories | 16 | 0% |
| Abbott Vascular | 1 | 0% |
| Horizon Medical Products | 1 | 0% |
| International Technidyne | 1 | 0% |
| Medtronic | 1 | 0% |
| Medtronic Heart Valves | 1 | 0% |
| Mentor | 1 | 0% |
| Smiths Medical International | 1 | 0% |
| Terumo Cardiovascular Systems | 1 | 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 and report source
Event type
Who filed
Grey bar: all 26,136,888 MAUDE reports.
Device problems coded
| Device problem (FDA code) | Reports | Share |
|---|---|---|
| Battery problema problem with the battery | 10,307 | 6.5% |
| Pumping problem | 9,578 | 6.1% |
| Mechanical problema mechanical problem | 8,768 | 5.5% |
| Infusion or flow problema problem with flow or infusion | 7,724 | 4.9% |
| Power problem | 7,049 | 4.5% |
| Other (for use when an appropriate device code cannot be identified) | 5,063 | 3.2% |
| Pumping stopped | 5,053 | 3.2% |
| Breakthe device broke | 4,132 | 2.6% |
| Connection problema connection problem | 3,910 | 2.5% |
| Electrical power problem | 3,315 | 2.1% |
| Disconnection | 3,194 | 2% |
| Material integrity problema problem with the device material | 2,965 | 1.9% |
| Electrical /electronic property probleman electrical or electronic problem | 2,948 | 1.9% |
| Insufficient device problem information | 2,887 | 1.8% |
| Complete loss of power | 2,741 | 1.7% |
| Device stops intermittentlythe device stopped now and then | 2,318 | 1.5% |
| Obstruction of flow | 2,076 | 1.3% |
| Decreased pump speed | 1,862 | 1.2% |
| Material twisted/bent | 1,539 | 1% |
| Device operates differently than expectedthe device behaved unexpectedly | 1,500 | 0.9% |
Questions about ventricular (assist) bypass reports
What is product code DSQ?
FDA's classification code for "Ventricular (assist) bypass", class 3, reviewed by the unknown panel. Every device report carries the product code of the device involved.
How many reports carry this code?
158,083 reports through August 2026, 9,332 of them in the latest 12 months.
Which brands appear most often?
HeartWare Ventricular Assist System - Pump (36,450), Heartware Ventricular Assist System (14,550), HeartMate 3 LVAS Implant Kit (13,500), Thoratec HeartMate 3 LVAS Implant Kit (8,129) and HeartMate 3 Left Ventricular Assist System (5,858). Widely used products collect more reports because more people use them.
Can the brands table be used to rank the devices?
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." Brands differ in how many are in use, how long they have been sold and how reports are collected.
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. 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.