Public recall detail

Everflex Self-Expanding Peripheral Stent With Entrust Delivery System

medium
Recall Safety notice
Quick summary

Quick summary: Everflex Self-Expanding Peripheral Stent With Entrust Delivery System.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Everflex Self-Expanding Peripheral Stent With Entrust Delivery System.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandEv3 Inc.
ProductEverflex Self-Expanding Peripheral Stent With Entrust Delivery System
IssueMedical devices - Performance
Recall classType II
IdentificationRA-64402

Affected products

ProductEverflex Self-Expanding Peripheral Stent With Entrust Delivery System
LotAll lots.
ModelEVX35-05-020-120 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
Serial numberAll lots.
DescriptionEverflex Self-Expanding Peripheral Stent With Entrust Delivery System
ProductEverflex Self-Expanding Peripheral Stent With Entrust Delivery System
LotAll lots.
ModelEVX35-07-150-120 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
Serial numberAll lots.
DescriptionEverflex Self-Expanding Peripheral Stent With Entrust Delivery System
ProductEverflex Self-Expanding Peripheral Stent With Entrust Delivery System
LotAll lots.
ModelEVX35-07-020-080 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
Serial numberAll lots.
DescriptionEverflex Self-Expanding Peripheral Stent With Entrust Delivery System

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Cardiovascular
CompaniesEv3 Inc. 4600 Nathan Lane North, Plymouth, Minnesota, United States, 55442
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-64402
Background{}
CompaniesEv3 Inc. 4600 Nathan Lane North, Plymouth, Minnesota, United States, 55442
AudiencesHealthcare
Source updated2022-07-25

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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