Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only

FDA device recall Z-1510-2025 · posted 2025-04-03 · Open, Classified

Recall details

Recalling firm

Cordis US Corp

Reason for recall

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

Action taken

On March 3, 2025, Cordis issued an "URGENT MEDICAL DEVICE RECALL" notification via FedEx. Cordis asked consignees to take the following actions: 1. Read this Urgent Medical Device Recall letter. 2. Immediately check your inventory for any units from the affected lot in your possession. Identify and quarantine any units from the identified lot in a manner that ensures the affected product will not be used. Check all storage and usage locations. 3. Share this letter with others in your facility who need to be made aware of this recall and with any other facility that may have been sent the affected units of product from your facility. If any units of the affected lots are found to be at the other facility, please arrange the return of the units. 4. Review, complete, sign and return the enclosed Acknowledgement Form directly to Cordis at the fax number on the form or email to: GMB-CordisFieldAction@cordis.com 5. Return any affected product to the address listed on the form, with reference to your Customer Number which is listed on the form. 6. Maintain awareness of this notice until all affected product has been returned to Cordis and keep a copy of this notice with the affected product. For questions related to the recall and/or acknowledgement form that are not adequately addressed in this letter, please contact Cordis QA at: GMB-CordisFieldAction@cordis.com or call Cordis Customer Support 1-800-327-7714 Option 2, Monday through Friday from 8:00 AM to 8:00 PM EDT.

Root cause

Employee error

Status

Open, Classified

Product code

NIO

Quantity affected

20 units

Distribution

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

Date initiated

2025-03-04

Date posted

2025-04-03

Location

Miami Lakes, FL