Drug recall
Plato 17 Microcatheter: Straight Tip, PL17-160-000; 45 degree Tip, PL17-160-045; 90 degree Tip, PL17-160-090
FDA recall event 91676 · Class II · Scientia Vascular, Inc.
Key facts
| Event ID | 91676 |
|---|---|
| Recall numbers | Z-1249-2023 |
| Recalling firm | Scientia Vascular, Inc. |
| Product type | Devices |
| Products | Plato 17 Microcatheter: Straight Tip, PL17-160-000 ; 45 degree Tip, PL17-160-045; 90 degree Tip, PL17-160-090 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Microcatheters for embolic coil and diagnostic agent introduction to peripheral/neuro vasculature, due to manufacturing non-conformance, and due to flush, guidewire insertion and manipulation prior to… |
| Initiation date | Feb 1, 2023 |
| Report date | Mar 22, 2023 |
| City | West Valley City |
| State | UT |
| Country | United States |
| FEI number | 3009546466 |
At a glance
- 1–9 Products in this recall
- 1–9 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: