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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall Edwards SAPIEN 3 Transcatheter Heart Valve (THV) see related information
Date Initiated by Firm June 11, 2018
Create Date July 13, 2018
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = EDWARDS LIFESCIENCES, LLC.
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