PMA · Approved
Recalled · 2009Abiomed BVS (R) 5000 BI-Ventricular Support System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abiomed Cardiovascular, Inc. · DSQ Ventricular (Assist) Bypass
Approved on Nov 20, 1992 through premarket approval, which rests on the device’s own clinical evidence after a 959-day review. It has been recalled 3 times.
- Decided
- Nov 20, 1992
- Review
- 959 days
- Class
- Class III
- Product code
- DSQ
- Recalls
- 3
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P900023 has 49 supplements since 1993: 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 |
|---|---|
| 1993 | 5 |
| 1994 | 5 |
| 1995 | 4 |
| 1996 | 5 |
| 1997 | 4 |
| 1998 | 3 |
| 1999 | 2 |
| 2000 | 4 |
| 2001 | 2 |
| 2003 | 3 |
| 2004 | 2 |
| 2005 | 2 |
| 2006 | 1 |
| 2007 | 3 |
| 2008 | 1 |
| 2009 | 2 |
| 2012 | 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 |
|---|---|---|---|---|
| Dec 16, 2009 | Not classified | Z-0824-2010 | Process control | Console shut down with no audible alarm |
| Apr 23, 2009 | Not classified | Z-1931-2009 | Device Design | iPulse Console SC1035 displayed a "Low Pressure / Low Flow" alarm and stopped pumping during patient transport in battery operation. |
| Aug 19, 2003 | Not classified | Z-1222-03 | Other | Bi-Ventricular support system may switch to battery when primary voltage (AC) is available |
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/P900023 · printed Nov 6, 2026
Cite this page
510(k) Report. “P900023: Abiomed BVS (R) 5000 BI-Ventricular Support System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P900023
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026