FDA recall Z-0137-2024

Maquet Cardiovascular, LLC · Class II · device

Product

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

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.

Distribution

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

Key facts

Status
Ongoing
Initiation date
2023-09-13
Report date
2023-11-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Wayne, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0137-2024