The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0728-2020·Announced 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'.

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 classified as FDA Class II and involves a labeling error regarding MRI safety. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries fall under Moderate severity.

Plain-English summary

Cardinal Health Inc. has initiated a labeling correction for the S.M.A.R.T. Nitinol Stent System and the S.M.A.R.T. Control Nitinol Stent System. The recall addresses incorrect information provided in the Instructions for Use (IFU) regarding the devices' safety during Magnetic Resonance Imaging (MRI) procedures.

The source text indicates that the IFU incorrectly classified the stents as "MRI Safe" when the correct classification is "MRI Conditional." This labeling error could potentially mislead healthcare providers regarding the safety of the devices in specific MRI environments. The affected products include self-expanding stents made of Nitinol (nickel-titanium alloy) designed for placement in the iliac artery.

The recall covers 267,247 units distributed worldwide, including 4,606 units in the United States. The affected SKUs are listed in the source metadata. Healthcare providers and patients should verify the MRI classification of these specific stent systems before undergoing MRI procedures.

The recalled product

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…
Manufacturer
Cardinal Health Inc.
Category
Medical Device — Vascular Stents
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: N1020ABR
  • N1020BBR
  • N1020TBR
  • N1040ABR
  • N1040BBR
  • N1040EBR
  • N1040TBR
  • N1060ABR
  • N1060BBR
  • N1060EBR
  • N1060TBR
  • N1080ABR
  • N1080BBR
  • N1080EBR
  • N1080TBR
  • N6120BV
  • N620ABR
  • N620BBR
  • N620TBR
  • N640ABR

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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.

See all 3 products in this recall →

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