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FDASeptember 13, 2023device

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 recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Ongoing

Brands named

maquet cardiovascularmaquet

UPCs

00607567100008

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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