Recall Z-0291-2024 ยท PRL Iliac Covered Stent, Arterial
Atrium Medical Corporation
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
| Date | Nov 11, 2023 (initiated Sep 21, 2023) |
| Status | Open, Classified |
| Reason | Balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment. |
| 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 shippe |
| Quantity | 141 units |
| Distribution | Foreign: Australia, Belgium, Canada, France, Germany, Greece, Malta, Netherlands, New Zealand, Portugal, and United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.