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Advanta v12

Official notice

7 Mar 2022

Last checked

7 Mar 2022

Medium riskHealth Canada

An official Health Canada notice concerns Advanta v12. Atrium/Getinge is initiating a voluntary medical device field correction for the Advanta V12 covered stent system due to an increased rate of customer complaints related to separation of the balloon or catheter hub from the delivery catheter during delivery system withdrawal. Recall start date: Mar 3. 2022 Published 2022-03-07.

What to do now

Contact the manufacturer if you require additional information.

Recall number

63969

Official notice

2022-03-07

The hazard

Atrium/Getinge is initiating a voluntary medical device field correction for the Advanta V12 covered stent system due to an increased rate of customer complaints related to separation of the balloon or catheter hub from the delivery catheter during delivery system withdrawal. Recall start date: Mar 3. 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

63969

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Affected products

Product 1

Affected Products - Advanta V12, Lot or Serial Number - All lots., Model or catalog number - 85326, 85329, 85334, 85338, 85353, 85388, 85389, 85398, 85321, 85327, 85333, 85343, 85344, 85371, 85390, 85328, 85332, 85340, 85352, 85391, 85323, 85325, 85336, 85337, 85354, 85364, 85324, 85335, 85351, 85361, 85365, 85372, 85322, 85331, 85345, 85350, 85379, 85397, 85320, 85355, 85360

Risk / hazard

Atrium/Getinge is initiating a voluntary medical device field correction for the Advanta V12 covered stent system due to an increased rate of customer complaints related to separation of the balloon or catheter hub from the delivery catheter during delivery system withdrawal. Recall start date: Mar 3. 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

Manufacturer

Not provided

Phone

Not provided

Brand: Atrium Medical, Advanta V12.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

63969

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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