# P160035: EXCOR Pediatric Ventricular Assist Device

- Pathway: PMA
- Applicant: Berlin Heart, Inc.
- Decided: Jun 6, 2017 after 299 days
- Product code: DSQ (Ventricular (Assist) Bypass)
- Device class: 3
- Recalls of this device: 2 (1 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.
1 of 1 device in its family (counting itself) has 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
- Apr 24, 2026 · Class II · Z-2320-2026: Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.
- May 18, 2018 · Class I · Z-1618-2023: There is a potential for a disruption in one or more of the triple layer membranes of the ventricular assist device. Recall occurred in 2018, and was retrospectively reported.

Source page: https://510kreport.com/device/P160035
Methodology: https://510kreport.com/methodology