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
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
S.M.A.R.T. Control Nitinol Stent
Lot or serial number
All lots.
Model or catalog number
More than 10 numbers, contact manufacturer.
Companies
- Manufacturer
-
Cordis Corporation
14201 NW 60TH AVE.
MIAMI LAKES
33014
Florida
UNITED STATES