Recall Z-2273-2023
Maquet Cardiovascular, LLC · initiated June 28, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ACROBAT V Vacuum Off-Pump System, Part Number C-OM-9100S. Component of a chest stabilization system for cardiac and chest surgery.
Codes / lots: UDI-DI: 00607567700536
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 taken
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
Details
- Recall number
- Z-2273-2023
- Initiated
- June 28, 2023
- Posted by FDA
- July 31, 2023
- Product code
- DWS – Instruments, Surgical, Cardiovascular
- Quantity
- 594 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.
- Recalling firm
- Maquet Cardiovascular, LLC, Wayne, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2271-2023 Class II | ACCESSRAIL Platform (Standard Blade) Part Number SB-1000, and (Deep Blades) Part Number…The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to… | 06/28/2023Open, Classified |
| Z-2272-2023 Class II | ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest…The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to… | 06/28/2023Open, Classified |
| Z-2274-2023 Class II | ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest…The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to… | 06/28/2023Open, Classified |