FDA Device recall Z-1235-2025
Plato 17 Microcatheter REF PL17-160-090 To assist in delivery of therapeutic devices and embolization materials and infusion of diagnostic…
- FDA Device
- Class II
- ongoing
- Published 2025-03-05
On 2025-03-05 the FDA classified a Class II recall of Plato 17 Microcatheter REF PL17-160-090 To assist in delivery of therapeutic devices and embolization materials and infusion of diagnostic… by Scientia Vascular, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1235-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-01-16 |
| Published | 2025-03-05 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Scientia Vascular |
| Distribution | US |
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
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.
Identifiers
| code_info | Catalog Number: PL17-160-090 UDI-DI code: 00818075010479 Lot Number: 031300 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1235-2025%22
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