Class 2 Device Recall Edwards SAPIEN 3 Transcatheter Heart Valve (THV)

• Date Initiated by Firm: June 11, 2018
• Create Date: July 13, 2018
• Recall Status: Terminated on May 23, 2019
• Recall Number: Z-2435-2018
• Recall Event ID: 80394
• PMA Number: P140031
• Product Classification: Aortic valve, prosthesis, percutaneously delivered - Product Code NPT
• Product: Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm
• Code Information: Use By: 2020-01-24, Serial #: 6005731, UDI #: (01)00690103194357(17)200124(21)6005731
• Recalling Firm/ Manufacturer: Edwards Lifesciences, LLC; 1 Edwards Way; Irvine CA 92614-5688
• For Additional Information Contact: 949-250-6827
• Manufacturer Reason for Recall: SAPIEN 3 THV was packaged with the incorrect valve size with respect to the label.
• FDA Determined Cause: Labeling False and Misleading
• Action: On 06/11/2018, the firm sent an Urgent Product Recall notice, via sales representative hand delivery, to the customer requesting they return the customer response form and the affected device. The customer was advised to call Customer Service at 1-800-424-3278, if they had any additional questions.
• Quantity in Commerce: 1 Valve
• Distribution: NJ
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = NPT