Z-1511-2025Class II

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

Name: Z-1511-2025 Cordis, REF: C09060ML, Smart Control Vascular Stent System ILIAC, 9mm X 60mm 6F, SterileEO, Rx Only
Creator: Cordis US Corp
Published: 2025-03-04
License: https://open.fda.gov/license/

Cordis US Corp. / initiated 2025-03-04 / Open, Classified / root cause: manufacturing process

FDA source

Cordis US Corp began a recall of Cordis, REF: C09060ML, Smart Control Vascular Stent System ILIAC, 9mm X 60mm 6F, SterileEO, Rx Only on 2025-03-04. FDA classified it as Class II and gives the reason as "product mix-up; Vascular stent labeled as one size but contains a different size". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1511-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-03-04
Posted: 2025-04-03
Recalling firm: Cordis US Corp.
Product: Cordis, REF: C09060ML, Smart Control Vascular Stent System ILIAC, 9mm X 60mm 6F, SterileEO, Rx Only
Product code: NIO Stent, Iliac
Reason for recall: product mix-up; Vascular stent labeled as one size but contains a different size.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: 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: [email protected] 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: [email protected] or call Cordis Customer Support 1-800-327-7714 Option 2, Monday through Friday from 8:00 AM to 8:00 PM EDT.
Quantity in commerce: 1 unit
Distribution: US Distribution to states of: AR, AZ, FL, NJ, TN; and OUS Foreign country of: Japan
Product codes and lots: Lot # 18298568/UDI:(01)20705032024430

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1511-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1510-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-09	2025-04-03
Z-1511-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-09	2025-04-03

Product code NIO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)