Maquet Cardiovascular, LLC: Medical Device Recall in 2023 - (Recall #: Z-2274-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest stabilization system for cardiac and chest surgery.

Product Classification:

Class II

Date Initiated: June 28, 2023

Date Posted: August 9, 2023

Recall Number: Z-2274-2023

Event ID: 92446

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.

Status: Ongoing

Product Quantity: 334 units

Code Information:

UDI-DI: 00607567700581

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.

Voluntary or Mandated:

Voluntary: Firm initiated