Reported Jul 25, 2018 · Terminated
Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm
Edwards Lifesciences, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Edwards Lifesciences, LLC · 1 Edwards Way · Irvine, CA · 92614-5688
Is this the product you have?
- Edwards SAPIEN 3 Transcatheter Heart Valve (THV)
- Model9600TFX
- Size26 mm
- Lot codes and dates
- Use By2020-01-24, Serial #: 6005731, UDI #: (01)00690103194357(17)200124(21)6005731
- Amount recalled
- 1 Valve
Where it was sold
Why it was recalled
SAPIEN 3 THV was packaged with the incorrect valve size with respect to the label.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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