Edwards Lifesciences, LLC: Medical Device Recall in 2018 - (Recall #: Z-2435-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm

Product Classification:

Class II

Date Initiated: June 11, 2018

Date Posted: July 25, 2018

Recall Number: Z-2435-2018

Event ID: 80394

Reason for Recall:

SAPIEN 3 THV was packaged with the incorrect valve size with respect to the label.

Status: Terminated

Product Quantity: 1 Valve

Code Information:

Use By: 2020-01-24, Serial #: 6005731, UDI #: (01)00690103194357(17)200124(21)6005731

Distribution Pattern:

Voluntary or Mandated:

Voluntary: Firm initiated