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Health product recall

Everflex Self-Expanding Peripheral Stent With Entrust Delivery System

Brand(s)
Ev3 Inc.
Last updated

Summary

Product
Everflex Self-Expanding Peripheral Stent With Entrust Delivery System
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

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
EVX35-05-080-080
EVX35-05-100-150
EVX35-05-150-150
EVX35-06-020-080
EVX35-06-040-080
EVX35-06-080-080
EVX35-06-120-120
EVX35-06-150-150
EVX35-07-120-150
EVX35-08-060-080
EVX35-08-060-120
EVX35-08-150-150
EVX35-05-060-120
EVX35-05-060-150
EVX35-05-150-080
EVX35-06-040-150
EVX35-06-060-120
EVX35-07-020-150
EVX35-07-060-150
EVX35-07-080-150
EVX35-07-150-080
EVX35-08-040-120
EVX35-05-100-120
EVX35-05-150-120
EVX35-06-020-120
EVX35-06-100-080
EVX35-06-150-080
EVX35-07-040-120
EVX35-07-060-080
EVX35-07-100-150
EVX35-08-040-150
EVX35-05-040-080
EVX35-05-060-080
EVX35-05-080-120
EVX35-05-120-150
EVX35-07-020-120
EVX35-07-100-080

Everflex Self-Expanding Peripheral Stent With Entrust Delivery System

All lots.

EVX35-07-150-120
EVX35-08-020-080
EVX35-08-020-120
EVX35-08-040-080
EVX35-08-080-080
EVX35-08-080-120
EVX35-08-100-150
EVX35-05-040-120
EVX35-05-120-120
EVX35-07-120-080
EVX35-07-150-150
EVX35-08-080-150
EVX35-08-120-150
EVX35-05-040-150
EVX35-05-080-150
EVX35-05-100-080
EVX35-06-020-150
EVX35-06-060-150
EVX35-06-080-150
EVX35-06-120-150
EVX35-06-150-120
EVX35-07-060-120
EVX35-07-080-080
EVX35-07-080-120
EVX35-07-100-120
EVX35-08-060-150
EVX35-05-020-150
EVX35-06-040-120
EVX35-06-060-080
EVX35-06-080-120
EVX35-06-100-150
EVX35-07-120-120
EVX35-08-100-080
EVX35-08-150-120
EVX35-05-020-080
EVX35-05-120-080
EVX35-06-100-120
EVX35-06-120-080

Everflex Self-Expanding Peripheral Stent With Entrust Delivery System

All lots.

EVX35-07-020-080
EVX35-07-040-080
EVX35-07-040-150
EVX35-08-020-150
EVX35-08-100-120
EVX35-08-120-080
EVX35-08-120-120
EVX35-08-150-080

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
Original published date: 2022-07-27
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies

Ev3 Inc.

4600 Nathan Lane North, Plymouth, Minnesota, United States, 55442

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-64402

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