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
Z-0137-2024
Product summary
- Event
- Event 93085
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2951 units
- Official record key
device-enforcement:Z-0137-2024
Official wording
Reason: 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.
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
Derived failure modes
-
Unknown
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.