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Everflex self-expanding peripheral stent with entrust delivery system

Official notice

25 Jul 2022

Last checked

25 Jul 2022

Medium riskHealth Canada

An official Health Canada notice concerns Everflex self-expanding peripheral stent with entrust delivery system. 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 Published 2022-07-25.

What to do now

Contact the manufacturer if you require additional information.

Recall number

64402

Official notice

2022-07-25

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

64402

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Affected products

Product 1

Affected products - Everflex Self-Expanding Peripheral Stent With Entrust Delivery System, Lot or serial number - All lots., Model or catalogue number - 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

Product 2

Affected products - Everflex Self-Expanding Peripheral Stent With Entrust Delivery System, Lot or serial number - All lots., Model or catalogue number - 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

Product 3

Affected products - Everflex Self-Expanding Peripheral Stent With Entrust Delivery System, Lot or serial number - All lots., Model or catalogue number - 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

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand: Ev3, Everflex Self-expanding Peripheral Stent With Entrust Delivery System.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

64402

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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