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

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.

Details from the source

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 Quantity: 2951 units Lot/code info: UDI-DI: 00607567100008 Lot Numbers: 3000188485, 3000193165, 3000193670, 3000195673, 3000198652, 3000199944, 3000201253, 3000204442

UPC codes

00607567100008

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.