Class 2 Device Recall ACROBATi

• Date Initiated by Firm: June 28, 2023
• Date Posted: July 31, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2274-2023
• Recall Event ID: 92446
• Product Classification: Instruments, surgical, cardiovascular - Product Code DWS
• Product: ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest stabilization system for cardiac and chest surgery.
• Code Information: UDI-DI: 00607567700581
• Recalling Firm/ Manufacturer: Maquet Cardiovascular, LLC; 45 Barbour Pond Dr; Wayne NJ 07470-2094
• For Additional Information Contact: Stephanie Moretti; 973-709-7170
• Manufacturer Reason for Recall: The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stabilization and positioning of heart, release of device component into the patient, and/or a procedural delay and/or conversion.
• FDA Determined Cause: Nonconforming Material/Component
• Action: An URGENT MEDICAL DEVICE Removal notification dated 6/28/23 was sent to customers. Actions to be taken by the customer: Our records indicate that you have received the ACCESSRAIL Platform (Standard Blade), ACCESSRAIL Platform (Deep Blades), ACROBAT SUV Vacuum Off-Pump System, ACROBAT V Vacuum Off-Pump System, or ACROBAT-i Vacuum Stabilizer System having one or more of the lot numbers that are affected by this recall. " Please examine your inventory immediately to determine if you have any of the ACCESSRAIL Platform (Standard Blades), ACCESSRAIL Platform (Deep Blades), ACROBAT SUV Vacuum Off-Pump System, ACROBAT V Vacuum Off-Pump System, or ACROBAT-i Vacuum Stabilizer System with the product codes/lot numbers listed in this notice. " If you have unused/unexpired affected product that you will be returning from your inventory, please contact Maquet/Getinge Customer Service at 888- 9GETUSA (888-943 8872) (option 2) between the hours of 8 AM and 6 PM Eastern Standard Time to request a return authorization number (RMA) and shipping instructions. o If you have affected product, you are entitled to a credit. You will receive credit upon your acknowledgement that you have affected product for return. o No new product is expected to exhibit this issue. " Please complete and sign the attached MEDICAL DEVICE Removal - RESPONSE FORM (pages 5 & 6) to acknowledge that you have received this notification. " Return the completed form to Maquet/Getinge by e-mailing a scanned copy to Acrobat-i2023.act@getinge.com or by faxing the form to +1(877) 589-3171. " Please forward this information to all current and potential ACCESSRAIL Platform (Standard Blades), ACCESSRAIL Platform (Deep Blades), ACROBAT SUV Vacuum Off-Pump System, ACROBAT V Vacuum Off-Pump System, or ACROBAT-i Vacuum Stabilizer 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 actio
• Quantity in Commerce: 334 units
• Distribution: Worldwide distribution - US Nationwide and the countries of Bangladesh, Brazil, Chile, Colombia, Iran, Jordan, Malaysia, Mexico, Netherlands, Singapore, Sudan, Taiwan, Thailand, and United Arab Emirates.
• 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.