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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is a voluntary labeling correction for a medical device. Per the rubric, minor labeling errors and voluntary precautionary recalls are classified as Moderate (Score 2).
Plain-English summary
Cardinal Health Inc. has initiated a labeling correction for Cordis S.M.A.R.T. CONTROL and S.M.A.R.T. Vascular Stent Systems. The recall addresses incorrect information provided in the Instructions for Use (IFU) regarding the devices' compatibility with Magnetic Resonance Imaging (MRI).
The source text indicates that the IFU incorrectly classified the stents as "MRI Safe." The correct classification for these devices is "MRI Conditional." This labeling error could lead to improper patient management or safety risks if the devices are exposed to MRI conditions without appropriate precautions.
The recall affects 267,247 units distributed worldwide, including 262,641 units outside the United States and 4,606 units within the United States. Affected products include various SKUs of the S.M.A.R.T. CONTROL and S.M.A.R.T. Vascular Stent Systems. Healthcare providers and patients should verify the MRI classification of their specific stent model and consult the updated labeling or the manufacturer for accurate safety information.
The recalled product
- 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…
- Manufacturer
- Cardinal Health Inc.
- Category
- Medical Device — Vascular Stent
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Part of a larger recall action
This product is one of 3 recalled by Cardinal Health Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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