Drug recall
Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures…
FDA recall event 93085 · Class II · Maquet Cardiovascular, LLC
Key facts
| Event ID | 93085 |
|---|---|
| Recall numbers | Z-0137-2024 |
| Recalling firm | Maquet Cardiovascular, LLC |
| Product type | Devices |
| Products | Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy incision approach. Product Code: OM-10000Z |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Sep 13, 2023 |
| Report date | Nov 1, 2023 |
| City | Wayne |
| State | NJ |
| Country | United States |
| FEI number | 2242352 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: