Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 19390 |
| Brand Name: | Medtronic Insync III Cardiac Resynchronization Therapy Pacemakers |
| Model: | 8042, 8042B, 8042U |
| Affected: | All serial numbers |
| Software version: | |
| Recalling Organisation: | Medtronic New Zealand Limited Unit 16 Mezzanine Level 5 Gloucester Park Road Onehunga AUCKLAND |
| Contact Information: | 0800 377 807 |
| Manufacturer: | Medtronic Inc |
| Issue: | Unexpected high battery impedance can result in the battery's inability to supply sufficient electrical current, impacting device function. Twelve (12) of the 30 devices had reports of unexpected loss of pacing capture. The other 18 devices experienced some form of erratic behavior, including early elective replacement indication (ERI), significant fluctuations in remaining longevity estimates, and inaccurate lead impedances. Through 27 October 2015, events associated with this issue have occurred in devices with implant durations of 53 months or more. |
| Recall action type: | Alert |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Healthcare Professional |
| Date Commenced: | 13/11/2015 |
