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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