FDA Device recall Z-1510-2025
Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only
- FDA Device
- Class II
- ongoing
- Published 2025-04-09
On 2025-04-09 the FDA classified a Class II recall of Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only by Cordis Us, citing product mix-up; Vascular stent labeled as one size but contains a different size.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1510-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-03-04 |
| Published | 2025-04-09 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Cordis Us |
| Distribution | AR, AZ, FL, NJ, TN |
Product
Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only
Reason
product mix-up; Vascular stent labeled as one size but contains a different size.
Identifiers
| code_info | Lot: 18298569/UDI: (01)20705032024591 |
|---|
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-1510-2025%22
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