Drug recall
VirtuoSaph Plus Endoscopic Vessel Harvesting System, Catalog Number: VSP550EX Product Usage: The VittuoSaph¿…
FDA recall event 81094 · Class II · Terumo Cardiovascular Systems Corporation
Key facts
| Event ID | 81094 |
|---|---|
| Recall numbers | Z-0227-2019 |
| Recalling firm | Terumo Cardiovascular Systems Corporation |
| Product type | Devices |
| Products | VirtuoSaph Plus Endoscopic Vessel Harvesting System, Catalog Number: VSP550EX Product Usage: The VittuoSaph¿ Plus Endoscopic Vessel Harvesting System VSP550EX is indicated for use in minimally… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The system's IFU contains a list of generators that the have been deemed compatible. Recent reports indicate that one energy platform is not compatible with the system. Therefore, it has been removed… |
| Initiation date | Aug 31, 2018 |
| Report date | Oct 31, 2018 |
| Termination date | Oct 21, 2019 |
| City | Elkton |
| State | MD |
| Country | United States |
| FEI number | 3000204839 |
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: