Maquet Cardiovascular, LLC recalls ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000.
Recalled Product
ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest stabilization system for cardiac and chest surgery.
Hazard / Issue
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.
Issued by
FDA
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