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HEART VALVE ACCESSORY
Edwards Lifesciences LLC · Model 1170 · UDI-DI 00690103019698
7
510(k) clearances
200
Adverse events
2
Recalls
22
Facilities
Description
OBTURATOR,AORTIC F/PRIMA 29MM F/USE W/2500PA VLV N/S
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-01-14 | Medtronic CoreValve LLC | Demonstration Simulus Reusable Sizer Accessory Kits were being incorrectly sourced to customers. The demonstration product (product used within a wet lab) could have come in conta |
| 2020-01-14 | Medtronic CoreValve LLC | Demonstration Simulus Reusable Sizer Accessory Kits were being incorrectly sourced to customers. The demonstration product (product used within a wet lab) could have come in conta |
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