The Recall Desk

FDA (Devices) recall action 84228

Cardinal Health Inc. recalled 3 products on 2020-01-01

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2020-01-01
Critical
0
Units
—

Why these products were 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".

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–3 of 3

  • ModerateFDA (Devices)··2020-01-01

    Cardinal Health Recalls S.M.A.R.T. Stents for Incorrect MRI Labeling

    Cardinal Health is correcting labeling on S.M.A.R.T. Nitinol Stent Systems that incorrectly stated they were 'MRI Safe' instead of 'MRI Conditional'.

    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
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2020-01-01

    Cordis Precise Nitinol Stent System Labeling Correction for MRI Information

    Cardinal Health is correcting labeling on Cordis Precise Nitinol Stent Systems because the instructions incorrectly stated the device was MRI Safe instead of MRI Conditional.

    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 ni
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2020-01-01

    Cardinal Health Recalls S.M.A.R.T. Stents for Incorrect MRI Labeling

    Cardinal Health is correcting labeling on S.M.A.R.T. stents that incorrectly stated they were MRI Safe. The correct classification is MRI Conditional.

    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 co
    Category
    Distribution
    1 state