# P140031: Sapien 3 Transcatheter Heart Valve and Accessories

- Pathway: PMA
- Applicant: Edwards Lifesciences, LLC
- Decided: Jun 17, 2015 after 177 days
- Product code: NPT (Aortic Valve, Prosthesis, Percutaneously Delivered)
- Device class: 3
- Recalls of this device: 3 (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
- Jan 22, 2019 · Class II · Z-0835-2019: This action has been initiated to address complaint reports received for crimp balloon and inflation balloon component separation during TAVR procedures.
- Jun 11, 2018 · Class II · Z-2435-2018: SAPIEN 3 THV was packaged with the incorrect valve size with respect to the label.
- Jul 21, 2017 · Class I · Z-0293-2018: A component in the Certitude Loader may have a molding overflow defect that could detach during advancement of the delivery system and potentially embolize from the loader into the patient.

Source page: https://510kreport.com/device/P140031
Methodology: https://510kreport.com/methodology