Class 2 Device Recall S.M.A.R.T. Nitinol Stent System and the S.M.A.R.T. Control Nitinol Stent System

• Date Initiated by Firm: November 14, 2019
• Create Date: December 20, 2019
• Recall Status: Open, Classified
• Recall Number: Z-0728-2020
• Recall Event ID: 84228
• PMA Number: P020036
• Product Classification: Stent, iliac - Product Code NIO
• Product: S.M.A.R.T. Nitinol Stent System and the S.M.A.R.T. Control Nitinol Stent System. The SMART stent system includes a self-expanding stent made of Nitinol (nickel-titanium alloy) material and a 6 French (2.0 mm) or 7 French (2.3 mm) sheathed delivery system. The stent is laser cut from a solid nitinol tube into a fine mesh ( Z Configuration) design. The stent expands to its unconstrained diameter when released from the deployment catheter into the iliac artery. Upon deployment, the stent forms an open lattice and pushes outward on the luminal surface, helping to maintain the patency of the artery. Due to the self-expanding behavior of nitinol, the stents are indicated for placement into vessels that are 1-2 mm smaller in diameter than the unconstrained diameter of the stent. The SMART Control stent system includes a self-expanding stent made of Nitinol (nickel-titanium alloy) material and a 6 French (2.0 mm) sheathed delivery system. The stent is laser cut from a solid nitinol tube into a fine mesh ( Z Configuration) design. The stent expands to its unconstrained diameter when released from the deployment catheter into the iliac artery. Upon deployment, the stent forms an open lattice and pushes outward on the luminal surface, helping to maintain the patency of the artery. Due to the self-expanding behavior of nitinol, the stents are indicated for placement into vessels that are 1-2 mm smaller in diameter than the unconstrained diameter of the stent. The stent is equipped with 12 tantalum markers, 6 at each end, to increase the visibility of the stent under fluoroscopic imaging. The SMART Control stent system is designed to be delivered through an appropriately sized catheter sheath introducer.
• Code Information: All Lot Codes. Affected SKUs: N1020ABR, N1020BBR, N1020TBR, N1040ABR, N1040BBR, N1040EBR, N1040TBR, N1060ABR, N1060BBR, N1060EBR, N1060TBR, N1080ABR, N1080BBR, N1080EBR, N1080TBR, N6120BV, N620ABR, N620BBR, N620TBR, N640ABR, N640BBR, N640TBR, N660ABR, N660BBR, N660TBR, N680ABR, N680BBR, N680TBR, N7120BV, N720ABR, N720BBR, N720TBR, N740ABR, N740BBR, N740TBR, N760ABR, N760BBR, N760TBR, N780ABR, N780BBR, N780TBR, N8120BV, N820ABR, N820BBR, N820TBR, N840ABR, N840BBR, N840EBR, N840TBR, N860ABR, N860BBR, N860EBR, N860TBR, N880ABR, N880BBR, N880EBR, N880TBR, N920ABR, N920BBR, N920TBR, N940ABR, N940BBR, N940TBR, N960ABR, N960BBR, N960TBR, N980ABR, N980BBR, N980TBR.
• Recalling Firm/ Manufacturer: Cardinal Health Inc.; 7000 Cardinal Pl; Dublin OH 43017-1091
• For Additional Information Contact: Cordis Endovascular Medical Info Line; 877-338-4235
• Manufacturer Reason for Recall: Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI information on the IFU. The correct classification is "MRI Conditional" not "MRI Safe".
• FDA Determined Cause: Under Investigation by firm
• Action: Customers were notified with a Medical Device Correction letter. The letter was sent via overnight delivery beginning 11/14/2019. The letter identified affected product, provided a description of the problem, and asked that a copy of the letter be retained where the product is stored. Customer were asked to completed and return an Acknowledgement Form. Questions can be directed to the Cordis Endovascular Medical Information Line 877-DEVICE5 (877-338-4235) Monday through Friday 9:00 am - 5:00 pm EST.
• Quantity in Commerce: 267,247 units total (262,641 OUS, 4,606 US)
• Distribution: Worldwide distribution - US Nationwide including Puerto Rico and countries of Algeria, Argentina, Armenia, Australia, Austria, Azerbaiian, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Czech Repulic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Guatemala, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Maldives, Malta, Martinique, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, Qatar, Russian Federation, Saint-Barthelemy, Saudia Arabia, Sinapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = NIO