Reported Nov 1, 2023 · Ongoing
Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a…
Maquet Cardiovascular, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Maquet Cardiovascular, LLC · 45 Barbour Pond Dr · Wayne, NJ · 07470-2094
Is this the product you have?
- Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy incision approach
- Product CodeOM-10000Z
- Lot codes and dates
- UDI-DI00607567100008
- Lot Numbers
30001884853000193165300019367030001956733000198652300019994430002012533000204442
- Amount recalled
- 2951 units
Where it was sold
- Nationwide
- DE
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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