Database updated: 3 November 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 28724 |
| Brand Name: | Sphincterotome Family of Devices |
| Model: | |
| Affected: | Multiple Batch numbers |
| Software version: | |
| Recalling Organisation: | Boston Scientific NZ Ltd 3 Diamond Street Eden Terrace Auckland 1021 |
| Contact Information: | 0800 742 678 |
| Manufacturer: | Boston Scientific Corporation |
| Issue: | The manufacturer is conducting a removal of specific lots of Sphincterotomesas. Through internal investigation, it has been determined that the inner pouch for the specified lots of devices impacted by this removal may be damaged which may compromise the sterile barrier. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 15/12/2021 |
