Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 29517 |
| Brand Name: | EXALT Model D Scope |
| Model: | D Single-Use Duodenoscope |
| Affected: | All |
| 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 doing the IFU update to highlight the known risk of perforation and provide best clinical practices related to insertion, advancement, and removal of this device. This information is consistent with the standard use of duodenoscopes in endoscopic retrograde cholangiopancreatography (ERCP) procedures. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 8/6/2022 |
