—#203631

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

FDA product code: PRL — Iliac Covered Stent, Arterial
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P120003
Affected lot / code info: UDI-DI: 00650862853612 Lot Numbers: 464909, 464910

Why it was recalled

Balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment.

Root cause (FDA determination)

Device Design

Action the firm took

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 tony.hawkins@getinge.com 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.

Recalling firm

Firm: Atrium Medical Corporation
Address: 40 Continental Blvd, Merrimack, New Hampshire 03054-4332

Distribution

Distribution pattern: Foreign: Australia, Belgium, Canada, France, Germany, Greece, Malta, Netherlands, New Zealand, Portugal, and United Kingdom

Timeline

Recall initiated: 2023-09-21
Posted by FDA: 2023-11-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #203631. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.