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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 4 of 4 Results
Related Medical Device Recalls
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Product Description
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FDA Recall
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Recalling Firm
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Z-2227-2019 - Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (29mm) 9630TF29 UDI:00690103201260 1 08/21/2019 Edwards Lifesciences, LLC
Z-2224-2019 - Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (20 mm) 9630TF20 UDI:00690103201239 1 08/21/2019 Edwards Lifesciences, LLC
Z-2225-2019 - Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (23mm) 9630TF23 UDI:00690103201246 1 08/21/2019 Edwards Lifesciences, LLC
Z-2226-2019 - Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (26mm) 9630TF26 UDI:00690103201253 1 08/21/2019 Edwards Lifesciences, LLC
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