Class 2 Device Recall CORDIS S.M.A.R.T. Control" Nitinol Stent System

• Date Initiated by Firm: March 10, 2008
• Date Posted: July 31, 2008
• Recall Status: Terminated on October 01, 2009
• Recall Number: Z-1556-2008
• Recall Event ID: 47347
• PMA Number: P020036
• Product Classification: Iliac Stent - Product Code NIO
• Product: CORDIS S.M.A.R.T. Control" Nitinol Stent System Model Number(s): C10040SL, Manufactured in Mexico. Indicated for improving luminal diameter in patients with symptomatic atherosclerotic disease.
• Code Information: 10 lots. Lot #s: 13326414*, 13326415*, 13327582, 13329185*, 13332369, 13333077*, 13339105*, 13339106*, 13341244, 13343464. (*These six lots have U.S. distribution.)
• Recalling Firm/ Manufacturer: Cordis Corporation; 14201 NW 60th Avenue; Miami Lakes FL 33014
• For Additional Information Contact: Hal Baden; 786-313-2000
• Manufacturer Reason for Recall: Data transcription error. The 10 affected lots of Catalog Number C10040SL were manufactured with a prior version of the guidewire lumen material, which is not validated with the current manufacturing process. This condition may result in a separation of the device. If a separation was to occur, and the separated fragment of lumen material was not retrieved on the guidewire, blockage of the vessel
• FDA Determined Cause: Mixed-up of materials/components
• Action: A letter (RE: Medical Device Recall) dated March 11, 2008, and Acknowledgement Form was sent overnight to the following 6 individuals in each account: Dir. Cardiac Cath Lab, Dir. Radiology Services, Dir. Vascular Services, Risk Manager, Materials Dir., Hospital Administrator; requesting that the affected product be set aside, and that the form be reviewed, signed, and faxed back to Cordis. Affected product is to be either returned or the local sales rep should the contacted to facilitate the return of the affected product. All product will be replaced. Customer Service can be contacted if there are additional questions relative to product return, replacement, or availability.
• Quantity in Commerce: 398 units
• Distribution: Worldwide Distribution --- including USA and countries of Japan and Canada.
• Total Product Life Cycle: TPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = NIO