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Recall Observatory FDA recall evidence

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

September 13, 2023

Class II

Product summary

Firm
Maquet Cardiovascular, LLC
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

    reason.no_named_rule · v1.0.0

    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.