Health product recall

Advanta V12 Covered Stent System

Last updated

Summary

Product
Advanta V12 Covered Stent System
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Advanta V12 Covered Stent System

More than 10 numbers, contact manufacturer.

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

Issue

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

Additional information

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

Atrium Medical Corporation

40 Continental Blvd., Merrimack, New Hampshire, United States, 03054

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-73917

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