Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 21608 |
| Brand Name: | EMBLEM MRI S-ICD Pulse Generator Model A219 |
| Model: | |
| Affected: | Model A209 and A219 |
| 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: | S-ICD |
| Model: | |
| Affected: | Model 1010 |
| Software version: | |
| Recalling Organisation: | Boston Scientific NZ Ltd 3 Diamond Street Eden Terrace Auckland 1021 |
| Contact Information: | 0800 742 678 |
| Manufacturer: | Cameron Health Inc |
| Brand Name: | EMBLEM S-ICD Pulse Generator |
| Model: | |
| Affected: | Model A209 and A219 |
| 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's engineers have determined that the patient's S-ICD repeatedly delivered an atypical amount of energy (similar to the arrhythmia induction function) because a specific memory location was corrupted by radiation1 within the environment. This repeated atypical energy delivery prevented S-ICD arrhythmia detection/treatment and ultimately contributed to the patient death. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Healthcare Professional |
| Date Commenced: | 30/6/2017 |
