Product Wiki · Recalls · Health Canada — Medical Devices

S.M.A.R.T. Control Nitinol Stent (2019-11-13) — recall 48054

Health Canada — Medical Devices · Canada · 2019-12-13 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
48054
Date of alert
2019-12-13
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Cordis became aware that the instructions for use (IFU) for the S.M.A.R.T. stents do not have correct language around the usage of the product with MRIS. The instructions for use (IFU) for multiple implantable products have "MRI safe" wording under the MRI compatibility information. This is not the currently correct terminology for implantable metals. Metallic implantable devices should be labeled as MRI conditional, so the IFUs are being updated to meet current us (FDA) and health Canada standards.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/smart-control-nitinol-stent-20

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