FDA-Device2022-09-07Class II
EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System
Medtronic Inc.
Hazard
Update to IFU provides a manual deployment workaround method to help mitigate potential harms related to partial stent deployment.
Sold states
worldwide
Affected count
183964 devices
Manufactured in
4600 Nathan Ln N, Plymouth, MN, United States
Products
EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1644-2022Don't want to check this manually?
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