Recall Z-2435-2018— Edwards Lifesciences, LLC
Class II · Terminated
Class II FDA medical device recall by Edwards Lifesciences, LLC, initiated 2018-06-11, terminated 2019-05-23. FDA's recall record names no specific 510(k) clearance for this event. Product: Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm. Reason: SAPIEN 3 THV was packaged with the incorrect valve size with respect to the label..
- Recalling firm
- Edwards Lifesciences, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-06-11
- Terminated
- 2019-05-23
- Firm location
- Irvine, CA, United States
Product description
Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm
Reason for recall
SAPIEN 3 THV was packaged with the incorrect valve size with respect to the label.
Data sourced from openFDA. This site is unofficial and independent of the FDA.