Plato 17 Microcatheter REF PL17-160-090 To assist in delivery of… — Class II medical device recall Z-1235-2025
Ongoing recall by Scientia Vascular, Inc., reported 2025-03-05, distributed nationwide. Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a result
| Recall number | Z-1235-2025 |
|---|---|
| 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 | 2025-01-16 |
| Classified | 2025-02-26 |
| Reported by FDA | 2025-03-05 |
| Distributed | Nationwide (US) |
| Quantity | 1 units |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 00818075010479 |
| Lot numbers | 031300 |
| Model numbers | PL17-160-090 |
Product
Plato 17 Microcatheter REF PL17-160-090 To assist in delivery of therapeutic devices and embolization materials and infusion of diagnostic agents to the neuro and peripheral vasculature during interventional or diagnostic procedures.
Reason for recall
Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a result, this could potential create a breach in the sterile barrier.
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-1235-2025. 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.