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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Cardinal Health Inc.: 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".

Agency Publication Date: December 20, 2019
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Affected Products

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

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.

Lot Numbers:
Codes
Product: 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 configuration) design. The delivery systems consist mainly of an inner shaft and an outer sheath with radiopaque markers, and a Tuohy Borst valve. The inner shaft terminates distally in

All Lot Codes. Affected SKUs: N1020SB, N1020SB, N1020SC, N1030SB, N1030SB, N1030SC, N1040SB, N1040SB, N1040SC, N520SB, N520SC, N530SB, N530SC, N540SB, N540SC, N620SB, N620SC, N630SB, N630SC, N640SB, N640SC, N720SB, N720SC, N730SB, N730SC, N740SB, N740SC, N820SB, N820SB, N820SC, N830SB, N830SB, N830SC, N840SB, N840SB, N840SC, N920SB, N920SB, N920SC, N930SB, N930SB, N930SC, N940SB, N940SB, N940SC, P05020RXB, P05030RXB, P05040RXB, P0520RXCE, P0530RXCE, P0540RXCE, P06020RXB, P06030RXB, P06040RXB, P0620RXCE, P0630RXCE, P0640RXCE, P07020RXB, P07030RXB, P07040RXB, P0720RXCE, P0730RXCE, P0740RXCE, P08020RXB, P08030RXB, P08040RXB, P0820RXCE, P0830RXCE, P0840RXCE, P09020RXB, P09030RXB, P0920RXCE, P0930RXCE, P0940RXCE, P10020RXB, P1020RXCE, P1030RXCE, P1040RXCE.

Lot Numbers:
Codes
Product: 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

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.

Lot Numbers:
Codes

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84228
Status: Active
Manufacturer: Cardinal Health Inc.
Manufactured In: United States
Units Affected: 3 products (267,247 units total (262,641 OUS, 4,606 US))

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.