FDA Device recall Z-0137-2024
Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy incision…
- FDA Device
- Class II
- ongoing
- Published 2023-11-01
On 2023-11-01 the FDA classified a Class II recall of Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy incision… by Maquet Cardiovascular, citing 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 gr….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0137-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-09-13 |
| Published | 2023-11-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Maquet Cardiovascular |
| Distribution | US |
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.
Identifiers
| code_info | UDI-DI: 00607567100008 Lot Numbers: 3000188485, 3000193165, 3000193670, 3000195673, 3000198652, 3000199944, 3000201253, 3000204442 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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FDA Device · Class II · 2025-09-24 · Maquet Cardiovascular - Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder
FDA Device · Class II · 2025-09-24 · Maquet Cardiovascular - Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder
FDA Device · Class II · 2025-09-24 · Maquet Cardiovascular
All Maquet Cardiovascular recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0137-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.