Class 2 Device Recall Atrium Medical

• Date Initiated by Firm: September 21, 2023
• Date Posted: November 11, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0291-2024
• Recall Event ID: 93195
• PMA Number: P120003
• Product Classification: Iliac covered stent, arterial - Product Code PRL
• 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
• Code Information: UDI-DI: 00650862853612 Lot Numbers: 464909, 464910
• Recalling Firm/ Manufacturer: Atrium Medical Corporation; 40 Continental Blvd; Merrimack NH 03054-4332
• For Additional Information Contact: SAME; 603-880-1433
• Manufacturer Reason for Recall: Balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment.
• FDA Determined 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 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.
• Quantity in Commerce: 141 units
• Distribution: Foreign: Australia, Belgium, Canada, France, Germany, Greece, Malta, Netherlands, New Zealand, Portugal, and United Kingdom
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = PRL and Original Applicant = ATRIUM MEDICAL CORP.