FDA recall Z-1511-2025

Cordis US Corp · Class II · device

Product

Cordis, REF: C09060ML, Smart Control Vascular Stent System ILIAC, 9mm X 60mm 6F, SterileEO, Rx Only

Reason for recall

product mix-up; Vascular stent labeled as one size but contains a different size.

Distribution

US Distribution to states of: AR, AZ, FL, NJ, TN; and OUS Foreign country of: Japan

Key facts

Status
Ongoing
Initiation date
2025-03-04
Report date
2025-04-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Miami Lakes, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1511-2025