Plato 17 Microcatheter: Straight Tip — Class II medical device recall Z-1249-2023
Ongoing recall by Scientia Vascular, Inc., reported 2023-03-22, distributed nationwide. Microcatheters for embolic coil and diagnostic agent introduction to peripheral/neuro vasculature, due to manu
| Recall number | Z-1249-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Scientia Vascular, Inc., West Valley City, UT, United States |
| Recall initiated | 2023-02-01 |
| Classified | 2023-03-13 |
| Reported by FDA | 2023-03-22 |
| Distributed | Nationwide (US) |
| Quantity | 353 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00818075010455, 00818075010462, 00818075010479 |
| Lot numbers | PL17-160-000/00818075010455 |
Product
Plato 17 Microcatheter: Straight Tip, PL17-160-000 ; 45 degree Tip, PL17-160-045; 90 degree Tip, PL17-160-090
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 placement, may have loose particles within catheter lumens that may be introduced to patients, which could cause embolic event, small vessel occlusion, and subacute to chronic inflammatory response.
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-1249-2023. 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.