Reported Jan 1, 2020 · Ongoing
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…
Cardinal Health Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cardinal Health Inc. · 7000 Cardinal Pl · Dublin, OH · 43017-1091
Is this the product you have?
- 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.
- Lot codes and dates
- All Lot Codes
- Affected SKUs
69 of 69 codes
N1020ABRN1020BBRN1020TBRN1040ABRN1040BBRN1040EBRN1040TBRN1060ABRN1060BBRN1060EBRN1060TBRN1080ABRN1080BBRN1080EBRN1080TBRN6120BVN620ABRN620BBRN620TBRN640ABRN640BBRN640TBRN660ABRN660BBRN660TBRN680ABRN680BBRN680TBRN7120BVN720ABRN720BBRN720TBRN740ABRN740BBRN740TBRN760ABRN760BBRN760TBRN780ABRN780BBRN780TBRN8120BVN820ABRN820BBRN820TBRN840ABRN840BBRN840EBRN840TBRN860ABRN860BBRN860EBRN860TBRN880ABRN880BBRN880EBRN880TBRN920ABRN920BBRN920TBR
- Amount recalled
- 267,247 units total (262,641 OUS, 4,606 US)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
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".
This product could cause temporary or reversible health problems — stop using it.
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