ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabilization system for cardiac and chest surgery.
Recall
- Recall Number
- Z-2272-2023
- Event Number
- 92446
- Firm
- Maquet Cardiovascular, LLC
- FEI Number
- 2242352
- Product Code
- DWS
- Status
- Open, Classified
- Root Cause
- Nonconforming Material/Component
- Initiated
- June 28, 2023
- Posted
- July 31, 2023
- Address
- 45 Barbour Pond Dr, Wayne, NJ, 07470-2094
Description
ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabilization system for cardiac and chest surgery.
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.
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 [email protected] 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
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.
401 units