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Advanta v12 covered stent system

Official notice

11 Jul 2023

Last checked

11 Jul 2023

Medium riskHealth Canada

An official Health Canada notice concerns Advanta v12 covered stent system. Atrium/Getinge is initiating a voluntary medical device field correction/notification 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: June 27, 2023 Published 2023-07-11.

What to do now

Contact the manufacturer if you require additional information.

Recall number

73917

Official notice

2023-07-11

The hazard

Atrium/Getinge is initiating a voluntary medical device field correction/notification 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: June 27, 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

73917

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Affected products

Product 1

Affected products - Advanta V12 Covered Stent System, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 85326 85329 85334 85338 85353 85388 85389 85398 85321 85327 85333 85343 85344 85371 85381 85390 85328 85332 85340 85352 85391 85323 85325 85336 85337 85354 85364 85380 85324 85335 85351 85361 85365 85372 85322 85331 85345 85350 85379 85397 85320

Risk / hazard

Atrium/Getinge is initiating a voluntary medical device field correction/notification 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: June 27, 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: Atrium Medical, Advanta V12 Covered Stent System.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

73917

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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