Z-2272-2023 Class II Ongoing
FDA device recall Z-2272-2023 was initiated by Maquet Cardiovascular, LLC on June 28, 2023 and is designated Class II. 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, rele… The recall status is ongoing. Affected quantity: 401 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 9, 2023
- Initiation Date
- June 28, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 401 units
Product Description
ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabilization system for cardiac and chest surgery.
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.
Distribution Pattern
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.
Code Information
UDI-DI: 00607567700543