CLASS II ONGOING Device recall · Reported 1 Jan 2020 · FDA Enforcement Report

Cordis S.M.A.R.T recalled by Cardinal Health

Cardinal Health is recalling Cordis S.M.A.R.T. Control /S.M.A.R.T. Vascular Stent System, distributed nationwide in the US. The recall was initiated on 14 Nov 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll Lot Codes. Affected SKUs: C06020MB, C06020MV, C06020SB, C06020SV, C06030MB, C06030MV, C06030SB, C06030SV, C06040MB, C06040MV, C06040SB, C06040SV, C06060MB, C06060MV, C06060SB, C06060SV, C06080MB, C06080MV, C06080SB, C06080SV, C06100MB, C06100MV, C06100SB, C06100SV, C07020MB, C07020MV, C07020SB, C07020SV, C07030MB, C07030MV, C07030SB, C07030SV, C07040MB, C07040MV, C07040SB, C07040SV, C07060MB, C07060MV, C07060SB, C07060SV, C07080MB, C07080MV, C07080SB, C07080SV, C07100MB, C07100MV, C07100SB, C07100SV, C08020MB, C08020MV, C08020SB, C08020SV, C08030MB, C08030MV, C08030SB, C08030SV, C08040MB, C08040MV, C08040SB, C08040SV, C08060MB, C08060MV, C08060SB, C08060SV, C08080MB, C08080MV, C08080SB, C08080SV, C08100MB, C08100MV, C08100SB, C08100SV, C09020MB, C09020MV, C09020SB, C09020SV, C09030MB, C09030MV, C09030SB, C09030SV, C09040MB, C09040MV, C09040SB, C09040SV, C09060MB, C09060MV, C09060SB, C09060SV, C09080MB, C09080MV, C09080SB, C09080SV, C09100MB, C09100MV, C09100SB, C09100SV, C10020MB, C10020MV, C10020SB, C10020SV, C10030MB, C10030MV, C10030SB, C10030SV, C10040MB, C10040MV, C10040SB, C10040SV, C10060MB, C10060MV, C10060SB, C10060SV, C10080MB, C10080MV, C10080SB, C10080SV, C10100MB, C10100MV, C10100SB, C10100SV, C12020MB, C12020MV, C12020SB, C12020SV, C12030MB, C12030MV, C12030SB, C12030SV, C12040MB, C12040MV, C12040SB, C12040SV, C12060MB, C12060MV, C12060SB, C12060SV, C12080MB, C12080MV, C12080SB, C12080SV, C14030MB, C14030MV, C14030SB, C14030SV, C14040MB, C14040MV, C14040SB, C14040SV, C14060MB, C14060MV, C14060SB, C14060SV, C14080MB, C14080MV, C14080SB, C14080SV.

Quantity recalled267,247 units total (262,641 OUS, 4,606 US)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0730-2020
FDA event ID: 84228
Recalling firm: Cardinal Health, Dublin, OH
Classification: Class II
Status: Ongoing
Recall initiated: 14 Nov 2019
FDA classified: 20 Dec 2019
Reported: 1 Jan 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Temperature Abuse
Device type: Heart & Vascular Devices

Timeline

14 Nov 2019	Recall initiated by company
20 Dec 2019	Classified by FDA	+36 days
1 Jan 2020	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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".

Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.

Product as listed by the FDA

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 S.M.A.R.T. CONTROL and S.M.A.R.T. Vascular Stents are designed to open to a preprogrammed diameter at body temperature. There are two delivery system configurations S.M.A.R.T. CONTROL and S.M.A.R.T. The stent is contained within the outer sheath of the delivery system. Once the distal end of the delivery system reaches the treatment site, the outer sheath of the delivery system is retracted to expose the stent and start its self-expansion. For the S.M.A.R.T. CONTROL Stent System, sheath retraction is achieved by grasping the handle in a fixed position with the tuning dial held between the thumb and index fingers, and rotating the tuning dial in a clockwise direction until the distal end of the stent is visibly apposed to the vessel wall. For the S.M.A.R.T. Stent System, sheath retraction is achieved by grasping the inner shaft in a fixed position and moving the outer sheath proximally relative t the inner shaft.

Where it was distributed

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.

Nationwide Puerto Rico

Questions about this recall

Why was it 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".

Which lots are affected?

All Lot Codes. Affected SKUs: C06020MB, C06020MV, C06020SB, C06020SV, C06030MB, C06030MV, C06030SB, C06030SV, C06040MB, C06040MV, C06040SB, C06040SV, C06060MB, C06060MV, C06060SB, C06060SV, C06080MB, C06080MV, C06080SB, C06080SV, C06100MB, C06100MV, C06100SB, C06100SV, C07020MB, C07020MV, C07020SB, C07020SV, C07030MB, C07030MV, C07030SB, C07030SV, C07040MB, C07040MV, C07040SB, C07040SV, C07060MB, C07060MV, C07060SB, C07060SV, C07080MB, C07080MV, C07080SB, C07080SV, C07100MB, C07100MV, C07100SB, C07100SV, C08020MB, C08020MV, C08020SB, C08020SV, C08030MB, C08030MV, C08030SB, C08030SV, C08040MB, C08040MV, C08040SB, C08040SV, C08060MB, C08060MV, C08060SB, C08060SV, C08080MB, C08080MV, C08080SB, C08080SV, C08100MB, C08100MV, C08100SB, C08100SV, C09020MB, C09020MV, C09020SB, C09020SV, C09030MB, C09030MV, C09030SB, C09030SV, C09040MB, C09040MV, C09040SB, C09040SV, C09060MB, C09060MV, C09060SB, C09060SV, C09080MB, C09080MV, C09080SB, C09080SV, C09100MB, C09100MV, C09100SB, C09100SV, C10020MB, C10020MV, C10020SB, C10020SV, C10030MB, C10030MV, C10030SB, C10030SV, C10040MB, C10040MV, C10040SB, C10040SV, C10060MB, C10060MV, C10060SB, C10060SV, C10080MB, C10080MV, C10080SB, C10080SV, C10100MB, C10100MV, C10100SB, C10100SV, C12020MB, C12020MV, C12020SB, C12020SV, C12030MB, C12030MV, C12030SB, C12030SV, C12040MB, C12040MV, C12040SB, C12040SV, C12060MB, C12060MV, C12060SB, C12060SV, C12080MB, C12080MV, C12080SB, C12080SV, C14030MB, C14030MV, C14030SB, C14030SV, C14040MB, C14040MV, C14040SB, C14040SV, C14060MB, C14060MV, C14060SB, C14060SV, C14080MB, C14080MV, C14080SB, C14080SV.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 84228

This product is part of a recall event; the main page for the event is Cordis Precise Nitinol Stent System recalled by Cardinal Health.

Reported	Class	Recall	Company	Reason	Where
1 Jan 2020	CLASS II	Cordis Precise Nitinol Stent System recalled by Cardinal Health	Cardinal Health	Other	Nationwide
1 Jan 2020	CLASS II	S.M.A.R.T. Nitinol Stent System recalled by Cardinal Health	Cardinal Health	Other	Nationwide

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