Database updated: 13 May 2024
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 17733 |
| Brand Name: | Medtronic 3f Enable Aortic Bioprosthesis |
| Model: | 6000 |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Medtronic New Zealand Limited Unit 16 Mezzanine Level 5 Gloucester Park Road Onehunga AUCKLAND |
| Contact Information: | 0800 377 807 |
| Manufacturer: | 3F Therapeutics Inc |
| Issue: | The manufacturer has updated the Instructions for Use (IFU) regarding the implantation of the Medtronic 3f Enable™ Aortic Bioprosthesis (Model 6000) to address the potential for valve migration after implant. While the current IFU provides guidelines and warnings designed to mitigate the procedural and patient factors that may contribute to migration, changes are being introduced to further reduce the possibility of such an event occurring. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 19/11/2014 |
