Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 20031 |
| Brand Name: | Sadra Medical Lotus Valve System |
| Model: | H749LTV230, H49LTV250, H749LTV270 |
| Affected: | All Batches |
| Software version: | |
| Recalling Organisation: | Boston Scientific NZ Ltd 3 Diamond Street Eden Terrace Auckland 1021 |
| Contact Information: | 0800 742 678 |
| Manufacturer: | Sadra Medical Inc (a subsidiary of Boston Scientific Corporation) |
| Issue: | Manufacturer is reinforcing the training requirements associated withthe use of the Lotus Valve System. A recent investigation identified a number of sites that had performed Lotus Valve cases without the mandatory support of a BSC Field Clinical Specialist (FCS). All Lotus Valve cases must be supported by a BSC FCS until the site is designated as “Independent” by Boston Scientific. |
| Recall action type: | Alert |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Sponsor Control |
| Date Commenced: | 21/4/2016 |
