FDA Device recall Z-1510-2013
FLEXSTENT Femoropopliteal Self-Expanding Stent System
- FDA Device
- Class II
- terminated
- Published 2013-06-12
On 2013-06-12 the FDA classified a Class II recall of FLEXSTENT Femoropopliteal Self-Expanding Stent System by Cordis, citing holes and/or tears can be introduced in the FLEXSTENT¿ inner pouch under some conditions, and to a lesser degree, in the outer pouch.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1510-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-04-23 |
| Published | 2013-06-12 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Cordis |
| Distribution | US |
Product
FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT¿ Femoropopliteal SES clinical product is indicated for treatment of atherosclerotic de novo native superficial femoral artery lesions and proximal popliteal lesions.
Reason
Holes and/or tears can be introduced in the FLEXSTENT¿ inner pouch under some conditions, and to a lesser degree, in the outer pouch.
Identifiers
| code_info | 32 Catalog Numbers FLX-50030-V1, FLX-60030-V1, FLX-70030-V1, FLX-80030-V1, FLX-50040-V1, FLX-60040-V1, FLX-70040-V1…32 Catalog Numbers FLX-50030-V1, FLX-60030-V1, FLX-70030-V1, FLX-80030-V1, FLX-50040-V1, FLX-60040-V1, FLX-70040-V1, FLX-80040-V1, FLX-50060-V1, FLX-60060-V1, FLX-70060-V1, FLX-80060-V1, FLX-50080-V1, FLX-60080-V1, FLX-70080-V1, FLX-80080-V1, FLX-50100-V1, FLX-60100-V1, FLX-70100-V1, FLX-80100-V1, FLX-50120-V1, FLX-60120-V1, FLX-70120-V1, FLX-80120-V1, FLX-50150-V1, FLX-60150-V1, FLX-70150-V1, FLX-80150-V1, FLX-50200-V1, FLX-60200-V1, FLX-70200-V1, FLX-80200-V1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1510-2013%22
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