Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm… recallZ-0291-2024 · Atrium Medical Corporation · initiated Sep 21, 2023
Class II Open, Classified All recalls posted in November 2023
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Atrium Medical Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-0291-2024
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Sep 21, 2023
- Posted by the FDA
- Nov 11, 2023
- Recalling firm
- Atrium Medical Corporation
- Quantity
- 141 units
- Product code
- PRL
- FDA submissions
- P120003
- Distribution
- Foreign: Australia, Belgium, Canada, France, Germany, Greece, Malta, Netherlands, New Zealand, Portugal, and United Kingdom
Product description
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
Code information (models, lots, serial numbers)
UDI-DI: 00650862853612 Lot Numbers: 464909, 464910
Other devices under the same FDA submission
17 devices cleared under P120003 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- iCast Covered Stent System, 6mmX16mmX120cm 42616Atrium Medical Corporation · Iliac Covered Stent, Arterial1 recall15 reports
- iCast Covered Stent System, 7mmX22mmX120cm 42722Atrium Medical Corporation · Iliac Covered Stent, Arterial8 reports
- iCast Covered Stent System, 6mmX38mmX120cm 42638Atrium Medical Corporation · Iliac Covered Stent, Arterial5 reports
- iCast Covered Stent System, 6mmX22mmX120cm 42622Atrium Medical Corporation · Iliac Covered Stent, Arterial4 reports
- iCast Covered Stent System, 5mmX22mmX120cm 42522Atrium Medical Corporation · Iliac Covered Stent, Arterial3 reports
- iCast Covered Stent System, 8mmX38mmX120cm 42838Atrium Medical Corporation · Iliac Covered Stent, Arterial3 reports
- iCast Covered Stent System, 9mmX59mmX120cm 42959Atrium Medical Corporation · Iliac Covered Stent, Arterial3 reports
- iCast Covered Stent System, 7mmX22mmX80cm 48722Atrium Medical Corporation · Iliac Covered Stent, Arterial3 reports
- iCast Covered Stent System, 10mmX38mmX120cm 42038Atrium Medical Corporation · Iliac Covered Stent, Arterial2 reports
- iCast Covered Stent System, 5mmX22mmX80cm 48522Atrium Medical Corporation · Iliac Covered Stent, Arterial2 reports
- iCast Covered Stent System, 9mmX38mmX80cm 48938Atrium Medical Corporation · Iliac Covered Stent, Arterial2 reports
- iCast Covered Stent System, 5mmX38mmX120cm 42538Atrium Medical Corporation · Iliac Covered Stent, Arterial1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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