Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 27613 |
| Brand Name: | Silk vista Intracranial self-expandable stent |
| Model: | |
| Affected: | All lots |
| Software version: | |
| Recalling Organisation: | Getz Healthcare Limited Level 17 120 Albert Street Auckland |
| Contact Information: | 0800 733 333 |
| Manufacturer: | Balt Extrusion SAS |
| Issue: | The manufacturer received a complaint about an error in the MRI information regarding the Silk Vista stent. It was noticed in the Instruction For Use (IFU) that the SAR (Specific Absorption Rate) value for the Silk Vista is incorrect 0.5W/kg at 1.5 Tesla and 0.6W/kg at 3 Tesla. This level makes the use of MRI impossible, as in normal imaging conditions the SAR exceeds those values. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 16/4/2021 |
