PMA · Approved
Recalled · 2009Heartmate VE Lvas
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thoratec Corp · DSQ Ventricular (Assist) Bypass
Approved on Sep 30, 1994 through premarket approval, which rests on the device’s own clinical evidence after a 914-day review. It has been recalled 2 times.
- Decided
- Sep 30, 1994
- Review
- 914 days
- Class
- Class III
- Product code
- DSQ
- Recalls
- 2
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P920014 has 27 supplements since 1995: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 1995 | 1 |
| 1996 | 2 |
| 1997 | 1 |
| 1998 | 1 |
| 1999 | 4 |
| 2000 | 3 |
| 2001 | 2 |
| 2002 | 1 |
| 2003 | 5 |
| 2004 | 2 |
| 2005 | 2 |
| 2007 | 1 |
| 2009 | 1 |
| 2011 | 1 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DSQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 14, 2009 | Not classified | Z-0422-2010 | Other | Patient reports alerted Thoratec that during the process of disconnecting power leads from the battery clips, the threaded connector of the battery clip housing was observed to be loose, and in some cases dislodged from the battery clip… |
| Jan 26, 2004 | Not classified | Z-0015-2007 | Other | During use an unexpected flaking of the inner surface coating (blood contact) that has the potential for risk of embolism. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All DSQ devicesDSQ Ventricular (Assist) Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DSQ
50in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSQ
Too few DSQ 510(k)s in any year since 2007 to give a median.
Recalls per year · DSQ
4in 2025
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · DSQ
10,419in 2025
MAUDE reports naming product code DSQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | — | 4 | 224 |
| 2008 | 5 | — | 1 | 264 |
| 2009 | 9 | — | 4 | 529 |
| 2010 | 12 | — | 1 | 687 |
| 2011 | 4 | — | 0 | 1,082 |
| 2012 | 20 | — | 1 | 2,120 |
| 2013 | 36 | — | 0 | 2,941 |
| 2014 | 30 | — | 0 | 3,903 |
| 2015 | 24 | — | 0 | 6,771 |
| 2016 | 37 | — | 2 (2) | 7,190 |
| 2017 | 36 | — | 0 | 9,055 |
| 2018 | 35 | — | 3 | 12,660 |
| 2019 | 34 | — | 1 | 20,216 |
| 2020 | 48 | — | 1 (1) | 14,239 |
| 2021 | 38 | — | 1 | 15,766 |
| 2022 | 33 | — | 11 | 15,994 |
| 2023 | 48 | — | 9 | 13,055 |
| 2024 | 61 | — | 1 (1) | 13,046 |
| 2025 | 50 | — | 4 | 10,419 |
| 2026 | 46 | — | 4 | — |
https://510kreport.com/device/P920014 · printed Nov 6, 2026
Cite this page
510(k) Report. “P920014: Heartmate VE Lvas.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P920014
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026