Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 13905 |
| Brand Name: | St Jude Medical Accent DR Dual Chamber Pacemaker, Model PM2212 |
| Model: | PM2112 |
| Affected: | Manufactured between Jul-2012 and Nov-2012 |
| Software version: | |
| Recalling Organisation: | Abbott Medical New Zealand Limited 4 Pacific Rise Mt Wellingtion Auckland 1640 |
| Contact Information: | 0800 756 269 |
| Manufacturer: | St Jude Medical (USA) |
| Brand Name: | St Jude Medical Accent SR Single Chamber Pacemaker, Model PM1110 |
| Model: | Model PM1110 |
| Affected: | Manufactured between Jul-2012 and Nov-2012 |
| Software version: | |
| Recalling Organisation: | Abbott Medical New Zealand Limited 4 Pacific Rise Mt Wellingtion Auckland 1640 |
| Contact Information: | 0800 756 269 |
| Manufacturer: | St Jude Medical (USA) |
| Issue: | Due to an incorrect software setting, these pacemakers will not provide a change in sensor driven, rate responsive pacing rates in response to patient physical activity. All other programmed parameters, features and functions operate as designed. Patients who are chronotropically incompetent and have their device programmed to a rate responsive mode will not experience a sensor driven rate increase when they are physically active. |
| Recall action type: | Alert |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Healthcare Professional |
| Date Commenced: | 10/12/2012 |
