Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System Recalled by Medtronic Inc. Due to Update to IFU provides a manual deployment workaround...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Inc. directly.
Affected Products
EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System
Quantity: 183964 devices
Why Was This Recalled?
Update to IFU provides a manual deployment workaround method to help mitigate potential harms related to partial stent deployment.
Where Was This Sold?
worldwide
About Medtronic Inc.
Medtronic Inc. has 85 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report