Cardinal Health recalls PRECISE Nitinol Stent Systems with incorrect MRI labeling. The devices are labeled "MRI Safe" instead of "MRI Conditional". This could cause issues with MRI scans. Consumers should check their product 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 PRECISE Nitinol Stent Systems because the labeling incorrectly states they are "MRI Safe" instead of "MRI Conditional." This could lead to unsafe MRI scans if used improperly. The recall affects all units with specific model codes.
The stents are labeled as "MRI Safe" when they should be "MRI Conditional." This means they could cause heating or damage during MRI scans if used incorrectly. The incorrect labeling does not pose an immediate risk during normal use but requires careful handling in MRI environments.
Medical professionals who use the PRECISE Nitinol Stent System for carotid artery procedures are most at risk. Patients receiving these stents may also be affected if they undergo MRI scans without proper precautions.
Check the product code on the stent packaging or label. Affected models include N1020SB, N1020SC, N1030SB, N1030SC, and many others listed in the recall notice. All units are affected regardless of lot code.
Look for the specific model codes listed in the recall notice, such as N1020SB or P05020RXB.
Reach out to Cardinal Health for further guidance on the recall and potential next steps.
The stents are labeled as "MRI Safe" instead of "MRI Conditional". This could cause issues during MRI scans if the stent is not properly handled.
No, the recall does not require stopping use. The hazard is a labeling error that affects MRI procedures, not the stent's safety during normal use.
Check the product code against the list provided in the recall notice and contact Cardinal Health for further instructions.
We’ve drafted a message you can send Cardinal Health to request your refund or repair — edit it as you like.
Subject: Recall Z-0729-2020 — Cardinal Health Cardinal Health Hello, I own a Cardinal Health that is covered by recall Z-0729-2020 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.
