Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 16363 |
| Brand Name: | Medtronic Activa PC Neurostimulator |
| Model: | Model: 37601 |
| Affected: | All devices |
| 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 Neurostimulator |
| Model: | Model: 37612 |
| Affected: | All devices |
| 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 Neurostimulator |
| Model: | Model: 37602 |
| Affected: | All devices |
| 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 Neurostimulator |
| Model: | Model: 37603 |
| Affected: | All devices |
| 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 RestoreADVANCED |
| Model: | Model: 37713 |
| Affected: | All devices |
| 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 |
| Model: | Model: 37712 |
| Affected: | All devices |
| 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 |
| Model: | Model: 37714 |
| Affected: | All devices |
| 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 PrimeADVANCED |
| Model: | Model: 37702 |
| Affected: | All devices |
| 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 SureScan MRI |
| Model: | Model: 97712 |
| Affected: | All devices |
| 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 RestoreADVANCED SureScan MRI |
| Model: | Model: 97713 |
| Affected: | All devices |
| 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 SureScan MRI |
| Model: | Model: 97714 |
| Affected: | All devices |
| 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 PrimeAdvanced SureScan MRI |
| Model: | Model: 97702 |
| Affected: | All devices |
| 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: | Medtronic has updated the labelling for Medtronic Deep Brain Stimulation (DBS), Spinal Cord Stimulation (SCS), and Peripheral Nerve Stimulation (PNS) Therapies to include the following. 1. Enabling cycling at certain parameter settings may decrease the recharge interval for rechargeable devices and the device longevity of non-rechargeable devices. Longevity calculations for non-rechargeable devices during SCS trailling with clycling enables as calculated on the N'Vision Clinician Programmer may not be accurate. 2. The current labelling does not address the potential for epidural mass formation and subsequent spinal cord compression. |
| Recall action type: | Alert |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Healthcare Professional |
| Date Commenced: | 12/3/2014 |
