Recall Z-1644-2022— Medtronic Inc.

Name: FDA recall Z-1644-2022
Creator: U.S. Food and Drug Administration
Published: 2022-07-14

Class II · Ongoing

Class II FDA medical device recall by Medtronic Inc., initiated 2022-07-14. FDA's recall record names no specific 510(k) clearance for this event. Product: EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System. Reason: Update to IFU provides a manual deployment workaround method to help mitigate potential harms related to partial stent deployment..

Recalling firm: Medtronic Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-07-14
Firm location: Plymouth, MN, United States

Product description

EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System

Reason for recall

Update to IFU provides a manual deployment workaround method to help mitigate potential harms related to partial stent deployment.

Data sourced from openFDA. This site is unofficial and independent of the FDA.