Maquet Cardiovascular, LLC: Medical Device Recall in 2023 - (Recall #: Z-0137-2024)

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:

Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy incision approach. Product Code: OM-10000Z

Product Classification:

Class II

Date Initiated: September 13, 2023

Date Posted: November 1, 2023

Recall Number: Z-0137-2024

Event ID: 93085

Reason for Recall:

Housing Mount Jaw of these devices breaking during normal use and may result in injury to the epicardial tissue or vasculature, or a coronary artery or previously placed bypass graft, or could result in procedural delay and/or conversion.

Status: Ongoing

Product Quantity: 2951 units

Code Information:

UDI-DI: 00607567100008 Lot Numbers: 3000188485, 3000193165, 3000193670, 3000195673, 3000198652, 3000199944, 3000201253, 3000204442

Distribution Pattern:

Nationwide Foreign: AT BE DE ES FR GB IT JP KR LU NL PL PT TR

Voluntary or Mandated:

Voluntary: Firm initiated