Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 20220 |
| Brand Name: | Medtronic Neuromodulation Lead Extensions |
| Model: | 7483 and 37086 |
| 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: | Post marketing surveillance for DBS therapy has identified the following serious events or injuries associated with tunneling that are not presented in the current DBS labeling. The following events are associated with the DBS implant and tunneling the extension from the lead to the INS: "Cases of spinal accessory nerve injury "Severe bleeding or vascular injury "An extension inadvertently implanted through the ribs and later found to be close to the heart requiring revision "Tunneling too superficially resulting in an extension that exited and then re-entered the neck which wasn't discovered until the surgical drape was removed |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Healthcare Professional |
| Date Commenced: | 2/6/2016 |
