Recalls / —
—#165357
Product
Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm
- FDA product code
- NPT — Aortic Valve, Prosthesis, Percutaneously Delivered
- Device class
- Class 3
- Medical specialty
- Unknown
- PMA numbers
- P140031
- Affected lot / code info
- Use By: 2020-01-24, Serial #: 6005731, UDI #: (01)00690103194357(17)200124(21)6005731
Why it was recalled
SAPIEN 3 THV was packaged with the incorrect valve size with respect to the label.
Root cause (FDA determination)
Labeling False and Misleading
Action the firm took
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.
Recalling firm
- Firm
- Edwards Lifesciences, LLC
- Address
- 1 Edwards Way, Irvine, California 92614-5688
Distribution
- Distribution pattern
- NJ
Timeline
- Recall initiated
- 2018-06-11
- Terminated
- 2019-05-23
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #165357. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.