Edwards SAPIEN 3 Transcatheter Heart Valve recall
Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm
Why was Edwards SAPIEN 3 Transcatheter Heart Valve recalled?
SAPIEN 3 THV was packaged with the incorrect valve size with respect to the label.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Use By: 2020-01-24, Serial #: 6005731, UDI #: (01)00690103194357(17)200124(21)6005731
- Product
- Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm
- Recalling firm
- Edwards Lifesciences, LLC
- Quantity
- 1 Valve
- Distribution
- NJ
- Recall date
- July 25, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)