Class 2 Device Recall Acrobati Vacuum Positioner System

• Date Initiated by Firm: October 31, 2023
• Date Posted: December 19, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0589-2024
• Recall Event ID: 93477
• Product Classification: Stabilizer, heart - Product Code MWS
• Product: Acrobat-i Vacuum Positioner System, Model Number XP-5000Z
• Code Information: UDI-DI: 00607567500006; Lot Numbers: 3000195267, 3000195268, 3000195273, 3000195663, 3000199248, 3000199725, 3000204637, 3000207240, 3000211594, 3000212053, 3000213219, 3000214053, 3000214054, 3000214255, 3000221064, 3000214052, 3000225770, 3000226531, 3000225866, 3000225769, 3000231209, 3000231210
• FEI Number: 2242352
• Recalling Firm/ Manufacturer: Maquet Cardiovascular, LLC; 45 Barbour Pond Dr; Wayne NJ 07470-2094
• Manufacturer Reason for Recall: The Positioner Arm may not tighten or lock during normal use.
• FDA Determined Cause: Component design/selection
• Action: An URGENT MEDICAL DEVICE Removal notification letter dated 10/31/23 was sent to customers. Actions to be taken by the customer: Our records indicate that you have received the Acrobat-i Vacuum Positioner System having one or more of the lot numbers that are affected by this medical device removal. Please examine your inventory immediately to determine if you have any of the Acrobat-i Vacuum Positioner Systems with the product codes/lot numbers listed in this notice and remove these from use. Return any unused/unexpired affected product to Maquet/Getinge. Please contact Maquet/Getinge Customer Service at 888-880-2874 between the hours of 6 AM and 5 PM Pacific Standard Time to request a return authorization (RMA) number and shipping instructions. You will receive credit upon your acknowledgement that you have affected product for return. Whether or not your facility has affected product(s) listed in this notice, please complete and sign the attached MEDICAL DEVICE REMOVAL - RESPONSE FORM (page 4 herein) to acknowledge that you have received this notification. Return the completed form to Maquet/Getinge by e-mailing a scanned copy to Acrobati-armnotlocking2023.act@getinge.com (please note the email address is case sensitive) or by faxing the form to 1-800-859-8365. Please forward this information to all current and potential Acrobat-i Vacuum Positioner System users within your hospital / facility. If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action. Actions to be taken by Getinge: Getinge will facilitate the removal of affected products from your facility and provide credit for your return of these products. This voluntary removal only affects the products listed on page 1; no other products are affected by this voluntary medical device removal. If you have any questions, please contact your Maquet/Getinge representative or call the Maquet/Getinge Customer Support a
• Quantity in Commerce: 6472 units
• Distribution: US Nationwide. Global Distribution.
• 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.