Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 28971 |
| Brand Name: | MicroVention gel coils |
| Model: | |
| Affected: | Multiple item codes |
| Software version: | |
| Recalling Organisation: | Culpan Distributors Ltd Unit 10 19 Hannigan Drive Mt Wellington Auckland |
| Contact Information: | 09 570 5752 |
| Manufacturer: | MicroVention Inc |
| Issue: | The manufacturer received notification of a labelling issue concerning the peel-off labels on certain lots of the HydroSoft 3D Endovascular Embolization Coil. Specifically, one of the four peel-off labels does not include reference to the HydroSoft 3D implant. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 14/2/2022 |
