Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Cordis S.M.A.R.T. CONTROL /S.M.A.R.T. Vascular Stent System. The S.M.A.R.T. CONTROL Recalled by Cardinal Health Inc. Due to Cordis has initiated a labeling correction for S.M.A.R.T....

Date: November 14, 2019
Company: Cardinal Health Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Cardinal Health Inc. directly.

Affected Products

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.

Quantity: 267,247 units total (262,641 OUS, 4,606 US)

Why Was This 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".

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Cardinal Health Inc.

Cardinal Health Inc. has 240 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report