Cardinal Health recalls SMART Nitinol stent systems due to incorrect MRI labeling. The product is labeled as 'MRI Safe' but should be 'MRI Conditional' for safe use with magnetic resonance imaging.
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 two stent systems that have incorrect MRI labeling. The stents are labeled as 'MRI Safe' but should be 'MRI Conditional' to ensure safe use with MRI machines.
The stents are incorrectly labeled as 'MRI Safe' when they should be 'MRI Conditional'. This means MRI scans could produce inaccurate images if the stents are in the body and the MRI machine is used without proper precautions.
Patients who received these stents for vascular procedures and medical professionals using the systems are affected. Those with MRI scans after stent placement may face incorrect MRI results due to the labeling error.
Check for the product names 'SMART Nitinol Stent System' or 'SMART Control Nitinol Stent System' with the listed lot codes. These stents were sold with incorrect MRI labeling.
Look for the product name and lot code on the stent packaging or device to confirm if it's affected.
Reach out to Cardinal Health for guidance on the correct MRI labeling and any necessary actions.
Cardinal Health initiated a labeling correction because the stents are incorrectly labeled as 'MRI Safe' when they should be 'MRI Conditional' for safe MRI use.
No, the recall is for labeling correction, not a safety issue. The stents can still be used but with proper MRI labeling.
Check the product label for the affected lot codes and contact Cardinal Health for guidance on the correct MRI labeling.
We’ve drafted a message you can send Cardinal Health to request your refund or repair — edit it as you like.
Subject: Recall Z-0728-2020 — Cardinal Health Cardinal Health Hello, I own a Cardinal Health that is covered by recall Z-0728-2020 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.
