Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 20478 |
| Brand Name: | Boston Scientific Lotus Valve System |
| Model: | H749LTV230, H749LTV250, H749LTV270 |
| Affected: | Multiple lots |
| 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: | There were a number of release mandrel breaks reported for product manufactured prior to the conponent change made in March 2016. The most common resolution was resheathing and removing the device without difficulty but resulting in procedural prolongation. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 8/8/2016 |
