# P900023: Abiomed BVS (R) 5000 BI-Ventricular Support System

- Pathway: PMA
- Applicant: Abiomed Cardiovascular, Inc.
- Decided: Nov 20, 1992 after 959 days
- Product code: DSQ (Ventricular (Assist) Bypass)
- Device class: 3
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Dec 16, 2009 · Not classified · Z-0824-2010: Console shut down with no audible alarm
- Apr 23, 2009 · Not classified · Z-1931-2009: 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: Bi-Ventricular support system may switch to battery when primary voltage (AC) is available

Source page: https://510kreport.com/device/P900023
Methodology: https://510kreport.com/methodology