Medical Device Recalls
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Recall
Class
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FDA Recall
Posting Date
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Recalling Firm
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| 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-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-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 |
| 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 |
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