The FDA announced on September 13, 2023, that Maquet Cardiovascular, LLC is recalling the Maquet Acrobat-i Vacuum Stabilizer System due to a housing mount jaw breakage hazard. The agency issued recall number Z-0137-2024 for the Class II device intended for cardiac surgical procedures.
How to tell if you have it
- Brand: Maquet
- Product: Maquet Acrobat-i Vacuum Stabilizer System
- Product Code: OM-10000Z
- UDI-DI: 00607567100008
- Lot Numbers: 3000188485, 3000193165, 3000193670, 3000195673, 3000198652, 3000199944, 3000201253, 3000204442
- Units affected: 2951
The hazard
According to the FDA, the housing mount jaw of these devices may break during normal use. This failure may result in injury to the epicardial tissue or vasculature, a coronary artery or previously placed bypass graft, or could result in procedural delay and/or conversion.
Context
GovInfoNow's records show Maquet Cardiovascular, LLC has 25 other recalls on record since January 24, 2019. Other recent recalls of similar products include Maquet Vasoview Hemopro 2 (June 2, 2026), Maquet Heartstring III Proximal Seal System (August 15, 2025), and Maquet Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (August 6, 2025). Other recent recalls of similar products include Acumed Hexalob Screw (May 28, 2026) and Merit Medical Custom Manifold Kit (December 4, 2025).