Cardinal Health recalls S.M.A.R.T. Vascular Stent Systems due to incorrect MRI labeling on instructions. The stents are labeled "MRI Safe" instead of "MRI Conditional". Affected models include C06020MB through C14080SV lot codes.
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".
Cardinal Health is recalling S.M.A.R.T. Vascular Stent Systems because the product labels incorrectly state they are "MRI Safe" instead of "MRI Conditional." This could lead to unsafe MRI scans if the stents are used in MRI machines. The recall affects specific model numbers and lot codes.
The stents are labeled as "MRI Safe" when they should be "MRI Conditional." This means they can be used in MRI machines only under specific conditions, not without restrictions. Using them without proper MRI protocols could cause damage to the stent or the patient.
Medical professionals who use the S.M.A.R.T. Vascular Stent Systems for procedures are affected. Patients with these stents may be at risk during MRI scans if the labeling error is not corrected.
Check the product label for model numbers starting with C06020MB through C14080SV. The recall covers all lot codes of these specific S.M.A.R.T. Vascular Stent Systems.
Look for model numbers starting with C06020MB through C14080SV on the stent packaging or label.
Cardinal Health is correcting the labeling to show the stents are "MRI Conditional" instead of "MRI Safe" to ensure safe MRI use.
No immediate action is required. The recall is a labeling correction, not a safety issue that requires stopping use or discarding the product.
All models with lot codes from C06020MB through C14080SV are affected.
We’ve drafted a message you can send Cardinal Health to request your refund or repair — edit it as you like.
Subject: Recall Z-0730-2020 — Cardinal Health Cardinal Health Hello, I own a Cardinal Health that is covered by recall Z-0730-2020 from Cardinal Health. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
