Class 2 Device Recall iCast Covered Stent

• Date Initiated by Firm: September 09, 2024
• Date Posted: October 07, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0024-2025
• Recall Event ID: 95329
• Product Classification: Iliac covered stent, arterial - Product Code PRL
• Product: iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616
• Code Information: UDI-DI: 00650862426168; Lot Number: 508083; Serial Numbers: 508083031, 508083032, 508083034, 508083035, 508083036, 508083037, 508083038, 508083039, 508083040, 508083041, 508083042
• Recalling Firm/ Manufacturer: Atrium Medical Corporation; 40 Continental Blvd; Merrimack NH 03054-4332
• For Additional Information Contact: 973-709-6929
• Manufacturer Reason for Recall: There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label.
• FDA Determined Cause: Under Investigation by firm
• Action: An Urgent Medical Device Removal notification letter dated 9/9/24 was sent to customers. Actions to be taken by the Customer: Our records indicate that you have received one or more of the iCast Covered Stents from the affected Product REF and Serial Numbers. Please examine your inventory immediately to determine if you have any of the iCast Covered Stents with the Product REF and Serial Numbers listed in this notice, which can be found on the product label. " Should you have any affected product, do not use the product and remove it from areas of use. " Please forward this information to all current and potential iCast Covered Stent System users within your hospital/ facility. " If you are a distributor who has shipped any affected product(s) to customers, please forward this document to their attention for appropriate action. " Please contact your local Atrium Medical Corporation/Getinge Customer Support department at (888) 943-8872 (press option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone) to receive instructions for returning any affected unused product within expiry per the iCast label. You will receive credit upon the return of any affected devices. " Whether or not you have affected product(s) with the Product REF number and Serial Numbers listed in this notice, please complete and sign the attached MEDICAL DEVICE - REMOVAL RESPONSE FORM to acknowledge that you have received this notification. Return the completed form to Getinge by emailing a scanned copy to trium.icastcooklabel.act@getinge.com. Type of Action by Atrium Medical Corporation/Getinge: If requested, Atrium Medical Corporation/Getinge will facilitate the removal of affected products from your facility and provide credit for your return of these products. If you have any questions, please call Atrium Medical Corporation/Getinge Customer Support at (888) 943-8872 (press option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m.
• Quantity in Commerce: 11 devices
• Distribution: US Nationwide distribution in the states of FL, MA, MI, OH, WA.
• 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.