Recall Z-0137-2024— Maquet Cardiovascular, LLC
Class II · Ongoing
Class II FDA medical device recall by Maquet Cardiovascular, LLC, initiated 2023-09-13. FDA's recall record names no specific 510(k) clearance for this event. 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. 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..
- Recalling firm
- Maquet Cardiovascular, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-09-13
- Firm location
- Wayne, NJ, United States
Product description
Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy incision approach. Product Code: OM-10000Z
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.