Drug recall
Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.
FDA recall event 97450 · Class II · Maquet Cardiovascular, LLC
Key facts
| Event ID | 97450 |
|---|---|
| Recall numbers | Z-2586-2025, Z-2587-2025, Z-2588-2025 |
| Recalling firm | Maquet Cardiovascular, LLC |
| Product type | Devices |
| Products | Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder., Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder., Heartstring III Proximal Seal System. Intravascular anastomosis occluder. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide… |
| Initiation date | Aug 15, 2025 |
| Report date | Sep 24, 2025 |
| 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: