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Maquet Cardiovascular, LLC recalls Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a s
Recalled November 1, 2023 · FDA recall Z-0137-2024 · Maquet Cardiovascular
Hazard
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. · FDA Class II
Units
2951 units
Sold at
Nationwide Foreign: AT BE DE ES FR GB IT JP KR LU NL PL PT TR
Description
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.
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
Manufacturer(s)
Maquet Cardiovascular, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →