Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 21148 |
| Brand Name: | Lotus Valve System |
| Model: | |
| Affected: | LOTUS TAVR 25mm H749LTV250, LOTUS TAVR 25mm H749LTV250, LOTUS TAVR 27mm H749LTV270 |
| 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: | The manufacturer has recently received a higher than anticipated number of reports of early pin release prior to locking the valve in the final position. If this occurs, the valve is unable to be fully locked, which requires the valve to be resheathed and removed from the patient prolonging the procedure. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 27/2/2017 |
