Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 25321 |
| Brand Name: | Emerge MR |
| Model: | |
| Affected: | Multiple Lots 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 |
| Brand Name: | NC Emerge MR PTCA Dilatation Catheter |
| Model: | |
| Affected: | Multiple lot 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: | Use of an impacted device could lead to increased frictional forces during device deliverability and withdrawal. The most serious foreseeable injury anticipated to occur due to lack of hydrophilic coating is a limited severity procedural delay to exchange the affected device. There is no additional follow up needed for patients who have already been treated with devices missing hydrophilic coating as the devices in scope of this action are not implanted. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 1/11/2019 |
