# P870072: Thoratec (R) Ventricular Assist Device (Vad) System

- Pathway: PMA
- Applicant: Thoratec Laboratories Corp.
- Decided: Dec 20, 1995 after 2,948 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
- Mar 30, 2007 · Not classified · Z-1109-2007: Incorrect collect nut assembly (inadvertent use of the incorrect (Black) collect nut) during surgical implantation (wrong size collect nut) to secure the inflow cannula to the PVAD has resulted in pat
- Sep 24, 2004 · Not classified · Z-0412-2007: The module power switch (at the back of console) may break while attempting to turn the Dual Drive Console OFF or ON.
- 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/P870072
Methodology: https://510kreport.com/methodology