FDA-Device2023-11-01Class II
Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy incision approach. Product Code: OM-10000Z
Maquet Cardiovascular, LLC
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.
Sold states
Nationwide Foreign: AT BE DE ES FR GB IT JP KR LU NL PL PT TR
Affected count
2951 units
Manufactured in
45 Barbour Pond Dr, N/A, Wayne, NJ, United States
Products
Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy incision approach. Product Code: OM-10000Z
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0137-2024Don't want to check this manually?
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