Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 21557 |
| Brand Name: | Inflation Device |
| Model: | |
| Affected: | Encore 26 Inflation Device Single Pack Multiple Lots |
| 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 has received reports indicating that the device trays have the potential to crack under certain handling conditions, such as impact during shipment. This issue has been attributed to a change in the material used in the packaging process. The complaints received for this issue have shown that this cracking, only occurs on one section of the device tray, potentially causing a sterile barrier breach. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 20/6/2017 |
