Everflex Self-Expanding Peripheral Stent With Entrust Delivery System
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
---|---|---|
Everflex Self-Expanding Peripheral Stent With Entrust Delivery System |
All lots. |
EVX35-05-020-120 |
Everflex Self-Expanding Peripheral Stent With Entrust Delivery System |
All lots. |
EVX35-07-150-120 |
Everflex Self-Expanding Peripheral Stent With Entrust Delivery System |
All lots. |
EVX35-07-020-080 |
Issue
Medtronic is informing customers about an update to instruction for use which provides a validated manual deployment workaround method to help mitigate potential harms related to the low risk of partial stent deployment.
Recall start date: July 14, 2022
Additional information
Details
Ev3 Inc.
4600 Nathan Lane North, Plymouth, Minnesota, United States, 55442