Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 16011 |
| Brand Name: | Medtronic Mosaic Heart Valve Sizer Sets |
| Model: | Model Numbers: 7305, 7305OD, 7305UX |
| Affected: | All lots |
| Software version: | |
| Recalling Organisation: | Medtronic New Zealand Limited Unit 16 Mezzanine Level 5 Gloucester Park Road Onehunga AUCKLAND |
| Contact Information: | 0800 377 807 |
| Manufacturer: | Medtronic Inc |
| Issue: | Medtronic has received infrequent reports of higher-than-expected transvalvular gradients occurring post implant. Medtronic has determined that the practice of substantial oversizing can lead to cases of higher-than-expected transvalvular gradients. Specifically, considerable oversizing, or implanting a valve substantially larger than the native aortic annulus, may result in the alteration of normal leaflet movement as blood flowing through the native annulus may not properly match the size and/or shape of the inflow of the Mosaic Aortic Bioprosthesis. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 14/1/2014 |
