Recall Z-2435-2018 ยท NPT Aortic Valve, Prosthesis, Percutaneously Delivered
Edwards Lifesciences, LLC
Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm
| Date | Jun 11, 2018 |
| Status | Terminated |
| Reason | SAPIEN 3 THV was packaged with the incorrect valve size with respect to the label. |
| Root 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 | 1 Valve |
| Distribution | NJ |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.