Food, drugs, devices › Cardinal Health Inc.
Device recall: 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-
FDA enforcement event 84228 is a device recall by Cardinal Health Inc. of Dublin, OH, initiated 14 Nov 2019 and classified Class II, with 3 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 968 device enforcement events initiated in 2019 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Cardinal Health Inc. has 12 enforcement events on this register, with a median of 3 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Cardinal Health Inc., Dublin, OH.
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"."
Distribution
"Worldwide distribution - US Nationwide including Puerto Rico and countries of Algeria, Argentina, Armenia, Australia, Austria, Azerbaiian, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Brazil,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0728-2020 | 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… | 267,247 units total (262,641 OUS, 4,606 US) | Class II | Ongoing | 1 Jan 2020 |
| Z-0729-2020 | Cordis Precise Nitinol Stent System. The Cordis PRECISE Nitinol Stent System devices are designed to deliver a flexible, self-expanding endoluminal stent to the carotid vasculature via over-the-wire (OTW) 5.5F or 6F sheathed delivery systems. The stent is cut from a solid nitinol tube into a fine mesh ( Z… | 267,247 units total (262,641 OUS, 4,606 US) | Class II | Ongoing | 1 Jan 2020 |
| Z-0730-2020 | Cordis S.M.A.R.T. CONTROL /S.M.A.R.T. Vascular Stent System. The S.M.A.R.T. CONTROL and S.M.A.R.T. Vascular Stent Systems consist of a self-expanding stent made of Nitinol (nickel-titanium alloy) material that is pre-mounted on an over-the-wire delivery system. The stents contain tantalum markers at each end. The… | 267,247 units total (262,641 OUS, 4,606 US) | Class II | Ongoing | 1 Jan 2020 |
Context
Other enforcement events for Cardinal Health Inc.
All 12 events for Cardinal Health Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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"."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution - US Nationwide including Puerto Rico and countries of Algeria, Argentina, Armenia, Australia, Austria, Azerbaiian, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Brazil,…"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.