Maquet Acrobat-i Vacuum Stabilizer System Intended for use during… — Class II medical device recall Z-0137-2024
Ongoing recall by Maquet Cardiovascular, LLC, reported 2023-11-01, distributed nationwide. Housing Mount Jaw of these devices breaking during normal use and may result in injury to the epicardial tissu
| Recall number | Z-0137-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Cardiovascular, LLC, Wayne, NJ, United States |
| Recall initiated | 2023-09-13 |
| Classified | 2023-10-22 |
| Reported by FDA | 2023-11-01 |
| Distributed | Nationwide (US) |
| Quantity | 2,951 units |
| UPC / GTIN / UDI-DI | 00607567100008 |
| Lot numbers | 3000188485, 3000193165, 3000193670, 3000195673, 3000198652, 3000199944, 3000201253, 3000204442 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0137-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.