Cardinal Health Inc. 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 fo Recall
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According to the U.S. Food and Drug Administration (FDA)
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 fo
Brand
Cardinal Health Inc.
Lot Codes / Batch Numbers
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.
Products Sold
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.
Cardinal Health Inc. is recalling S.M.A.R.T. Nitinol Stent System and the S.M.A.R.T. Control Nitinol Stent System. The SMART stent due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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".
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026