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U.S. Department of Health and Human Services

Class 2 Device Recall Vascular Stent System

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 Class 2 Device Recall Vascular Stent Systemsee related information
Date Initiated by FirmMarch 04, 2025
Date PostedApril 03, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1511-2025
Recall Event ID 96418
Product Classification Stent, iliac - Product Code NIO
ProductCordis, REF: C09060ML, Smart Control Vascular Stent System ILIAC, 9mm X 60mm 6F, SterileEO, Rx Only
Code Information Lot # 18298568/UDI:(01)20705032024430
FEI Number 1016427
Recalling Firm/
Manufacturer		 Cordis US Corp
14201 Nw 60th Ave
Miami Lakes FL 33014-2802
For Additional Information ContactCordis Customer Support
1800-327-7714 Ext. 2
Manufacturer Reason
for Recall		product mix-up; Vascular stent labeled as one size but contains a different size.
FDA Determined
Cause 2		Employee error
ActionOn 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.
Quantity in Commerce1 unit
DistributionUS Distribution to states of: AR, AZ, FL, NJ, TN; and OUS Foreign country of: Japan
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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