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Cordis S.M.A.R.T. Control Vascular Stent System recallZ-1510-2025 · Cordis US Corp · initiated Mar 4, 2025

Class II Open, Classified All recalls posted in April 2025

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Cordis US Corp or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Employee error

What the company is doing

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.

Recall details

Recall number
Z-1510-2025
Recall class
Class II
Status
Open, Classified
Initiated by the company
Mar 4, 2025
Posted by the FDA
Apr 3, 2025
Recalling firm
Cordis US Corp
Quantity
20 units
Product code
NIO
FDA submissions
P020036
Distribution
US Distribution to states of: AR, AZ, FL, NJ, TN; and OUS Foreign country of: Japan

Product description

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

Code information (models, lots, serial numbers)

Lot: 18298569/UDI: (01)20705032024591

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

37 devices cleared under P020036 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 96418).

Sources and updates

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