Recall Z-2273-2023 ยท DWS Instruments, Surgical, Cardiovascular
Maquet Cardiovascular, LLC
ACROBAT V Vacuum Off-Pump System, Part Number C-OM-9100S. Component of a chest stabilization system for cardiac and chest surgery.
| Date | Jul 31, 2023 (initiated Jun 28, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root 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 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.