# FDA recall Z-0728-2020

> **Cardinal Health Inc.** · Class II · device recall initiated 2019-11-14.

## 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 

## 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, 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.

## Key facts

- **Recall number:** Z-0728-2020
- **Recalling firm:** Cardinal Health Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-11-14
- **Report date:** 2020-01-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Dublin, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0728-2020

## Citation

> AI Analytics. FDA recall Z-0728-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0728-2020. Source: US FDA. Licensed CC0.

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