Health product recall

Fred® Flow Re-Direction Endoluminal Device

Last updated

Summary

Product
Fred® Flow Re-Direction Endoluminal Device
Issue
Medical devices - Performance
What to do

Instructions provided to return affected products for replacement. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Fred® Flow Re-Direction Endoluminal Device

20092955K
20092859F
200922536
20071655K
20081255H
2009085AU
20092853Z
20092957L

FRED5526
FRED4539
FRED4012
FRED5514
FRED3536

Issue

It has been determined that product manufactured between June 1, 2020, and September 29, 2020, may be manufactured with an incorrect inner stent length and may not perform as intended.

Recall start date: June 7, 2023

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Neurology
Companies

Microvention, Inc.

35 Enterprise, Aliso Viejo, California, United States, 92656

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-74058

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