Z-0291-2024Class II

Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restoring and improving the...

Name: Z-0291-2024 Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restoring and improving the...
Creator: Atrium Medical Corporation
Published: 2023-09-21
License: https://open.fda.gov/license/

Atrium Medical Corporation / initiated 2023-09-21 / Open, Classified / root cause: design

FDA source

Atrium Medical Corporation began a recall of Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restoring and improving the patency of the iliac andrenal arteries. Renal... on 2023-09-21. FDA classified it as Class II and gives the reason as "Balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0291-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-09-21
Posted: 2023-11-11
Recalling firm: Atrium Medical Corporation
Product: Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restoring and improving the patency of the iliac andrenal arteries. Renal approval includes 5mm, 6mm and 7mm diameter Advanta V12 covered stent sizes. In Canada, the Advanta V12 Covered Stent indication excludes renal arteries. REF: 85361
Product code: PRL Iliac Covered Stent, Arterial
Reason for recall: Balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment.
Root cause tag: design
FDA root cause: Device Design
Action: Atrium/Getinge issued URGENT Field Safety Notice -MEDICAL DEVICE REMOVAL on 9/25/23. Letter states reason for recall, health risk and action to take: Please examine your inventory immediately to determine if you have any of the Advanta V12 covered stent product listed above. Should you have any affected product, please remove from area(s) of use. If you have affected product, you are entitled to a replacement at no cost to your facility or credit. You will receive a replacement/credit upon your acknowledgement that you have affected product for return. If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action. Once your customer response form has been received you will be contacted with shipping instructions to return any affected product. Whether or not you have affected product(s) with a LOT number listed in this notice, please complete and sign the attached MEDICAL DEVICE- REMOVAL RESPONSE FORM (page 3) to acknowledge that you have received this notification. Return the completed form to Atrium/Getinge to [email protected] Type of Action by Getinge: Atrium/Getinge has identified the cause of the issue and has implemented corrective measures to resolve the noted manufacturing deficiency in the welding process, as well as additional detection measures implemented to detect balloon weld defects. These corrective actions were implemented September 09, 2020. Product Manufactured through the welding process after September 09, 2020 is not affected by this recall. If you have affected product, you will receive a replacement at no cost to your facility, or credit. If you have any questions, please contact your Getinge representative or office.
Quantity in commerce: 141 units
Distribution: Foreign: Australia, Belgium, Canada, France, Germany, Greece, Malta, Netherlands, New Zealand, Portugal, and United Kingdom
Product codes and lots: UDI-DI: 00650862853612 Lot Numbers: 464909, 464910

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0291-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0291-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-22	2023-11-10

Product code PRL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)