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

Starting date:

November 13, 2019

Posting date:

December 13, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-71859

Last updated: 2019-12-13

• Reason
• Affected products

Affected Products

S.M.A.R.T. Control Nitinol Stent

Reason

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.

Affected products