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Fred® flow re-direction endoluminal device

Official notice

4 Nov 2024

Last checked

4 Nov 2024

Medium riskHealth Canada

An official Health Canada notice concerns Fred® flow re-direction endoluminal device. 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 Published 2024-11-04.

What to do now

Instructions provided to return affected products for replacement.

Recall number

74058

Official notice

2024-11-04

The hazard

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

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

74058

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Affected products

Product 1

Affected products - Fred® Flow Re-Direction Endoluminal Device, Lot or serial number - 20092955K 20092859F 200922536 20071655K 20081255H 2009085AU 20092853Z 20092957L, Model or catalog number - FRED5526 FRED4539 FRED4012 FRED5514 FRED3536

Risk / hazard

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

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

Manufacturer

Not provided

Phone

Not provided

Brand: Microvention, Fred® Flow Re-direction Endoluminal Device.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

74058

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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