Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm
Reported: July 25, 2018 Initiated: June 11, 2018 #Z-2435-2018
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.
Details
- Recalling Firm
- Edwards Lifesciences, LLC
- Units Affected
- 1 Valve
- Distribution
- NJ
- Location
- Irvine, CA
Frequently Asked Questions
What product was recalled? ▼
Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm. Recalled by Edwards Lifesciences, LLC. Units affected: 1 Valve.
Why was this product recalled? ▼
SAPIEN 3 THV was packaged with the incorrect valve size with respect to the label.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 25, 2018. Severity: Moderate. Recall number: Z-2435-2018.
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