Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 26967 |
| Brand Name: | EMBLEM™ MRI S-ICD Pulse Generator Model A219 |
| Model: | (Model A209 and A219) |
| Affected: | |
| 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: | EMBLEM S-ICD Pulse Generator |
| Model: | (Model A209 and A219) |
| Affected: | |
| 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 confirmed six (6) events of EMBLEM S-ICD electrical overstress malfunctions that have occurred in association with delivery of high voltage therapy |
| Recall action type: | Alert |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 3/12/2020 |
