# P100041: Edwards Sapien Transcatheter Heart Valve  and Accessories

- Pathway: PMA
- Applicant: Edwards Lifesciences, LLC
- Decided: Nov 2, 2011 after 366 days
- Product code: NPT (Aortic Valve, Prosthesis, Percutaneously Delivered)
- 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
- Jan 20, 2014 · Class II · Z-0918-2014: Edwards Lifesciences is recalling two lot numbers of the 26mm transcatheter heart valve crimper because they may not open sufficiently when the handle is rotated in the full open position. As a result
- Mar 26, 2013 · Class II · Z-1134-2013: Holes in the sterile barrier pouch may be caused by handling of the device during manufacturing or once pouches have been removed from the unit box and stored on the shelf by customers.
- Mar 26, 2013 · Class II · Z-1135-2013: Holes in the sterile barrier pouch may be caused by handling of the device during manufacturing or once pouches have been removed from the unit box and stored on the shelf by customers.

Source page: https://510kreport.com/device/P100041
Methodology: https://510kreport.com/methodology