Recall Z-2435-2018
Edwards Lifesciences, LLC · initiated June 11, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm
Codes / lots: Use By: 2020-01-24, Serial #: 6005731, UDI #: (01)00690103194357(17)200124(21)6005731
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 taken
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.
Details
- Recall number
- Z-2435-2018
- Initiated
- June 11, 2018
- Terminated
- May 23, 2019
- Product code
- NPT – Aortic Valve, Prosthesis, Percutaneously Delivered
- Quantity
- 1 Valve
- Distribution
- NJ
- Recalling firm
- Edwards Lifesciences, LLC, Irvine, CA