Advanta V12 Covered Stent System
Brand(s)
Last updated
Summary
Product
Advanta V12 Covered Stent System
Issue
Medical devices - Performance
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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