Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 16080 |
| Brand Name: | Medtronic Activa PC 37601 Neurostimulator |
| Model: | Model 37601 |
| Affected: | |
| 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 |
| Brand Name: | Medtronic Activa SC 37602 Neurostimulator |
| Model: | Model 37602 |
| Affected: | |
| 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 |
| Brand Name: | Medtronic Activa SC 37603 Neurostimulators |
| Model: | Model 37603 |
| Affected: | |
| 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 |
| Brand Name: | Medtronic Activa RC 37612 Neurostimulator |
| Model: | Model 37612 |
| Affected: | |
| 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 |
| Brand Name: | Medtronic RestoreULTRA 37712 Neurostimulator |
| Model: | Model 37712 |
| Affected: | |
| 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 |
| Brand Name: | Medtronic RestoreSensor 37714 Neurostimulators |
| Model: | Models 37714 |
| Affected: | |
| 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: | 1) Unexpected Loss of stimulation may occur under the following conditions: - Switching from a group with two programs to a group with three or four programs where a non-negative contact is shared within the programmed groups. - Creating Program Groups (Activa SC only) when a second program is created for the first time. 2) Under a specific set of conditions (Activa SC - Models 37602 / 37603 are not affected), typically related to device recovery from an over discharge, there is a potential for over stimulation or stimulation directed to a lead electrode other than what was intended: - Device reaches a power on reset (POR) state. A POR may be detected during interrogation with the patient or physician programmer. The patient will experience loss of therapy if a POR occurs. - 'Therapy OFF' command is sent (by patient programmer, INSR, or 'THERAPY-STOP' button on the 8840 clinician programmer) to device while the device is making an automatic periodic battery measurement. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Healthcare Professional |
| Date Commenced: | 30/1/2014 |
