Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 25511 |
| Brand Name: | Cordis_SMART CONTROL Stents |
| Model: | |
| Affected: | Multiple lot numbers |
| Software version: | |
| Recalling Organisation: | InterMed Medical Ltd 71 Apollo Drive Albany AUCKLAND 1311 |
| Contact Information: | 0800 333 444 |
| Manufacturer: | Cordis Corporation |
| Issue: | The manufacturer became aware that the Instructions for Use (IFU) for specific families of 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 labelled as MRI conditional, so the IFUs are being updated to meet current US (FDA) and OUS (international ISO) standards. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 7/1/2020 |
