Home / Recalls / Medical Devices
Medtronic Inc. recalls EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System
Recalled September 7, 2022 · FDA recall Z-1644-2022 · Medtronic
Hazard
Update to IFU provides a manual deployment workaround method to help mitigate potential harms related to partial stent deployment. · FDA Class II
Units
183964 devices
Sold at
worldwide
Description
Update to IFU provides a manual deployment workaround method to help mitigate potential harms related to partial stent deployment.
Product
EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System
Manufacturer(s)
Medtronic Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →