# P920014: Heartmate VE Lvas

- Pathway: PMA
- Applicant: Thoratec Corp
- Decided: Sep 30, 1994 after 914 days
- Product code: DSQ (Ventricular (Assist) Bypass)
- Device class: 3
- Recalls of this device: 2 (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
- Oct 14, 2009 · Not classified · Z-0422-2010: 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 c
- Jan 26, 2004 · Not classified · Z-0015-2007: During use an unexpected flaking of the inner surface coating (blood contact) that has the potential for risk of embolism.

Source page: https://510kreport.com/device/P920014
Methodology: https://510kreport.com/methodology