Recall Z-2272-2023— Maquet Cardiovascular, LLC

Name: FDA recall Z-2272-2023
Creator: U.S. Food and Drug Administration
Published: 2023-06-28

Class II · Ongoing

Class II FDA medical device recall by Maquet Cardiovascular, LLC, initiated 2023-06-28. FDA's recall record names no specific 510(k) clearance for this event. Product: ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabilization system for cardiac and chest surgery.. 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..

Recalling firm: Maquet Cardiovascular, LLC
Classification: Class II
Status: Ongoing
Initiated: 2023-06-28
Firm location: Wayne, NJ, United States

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.