Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 24903 |
| Brand Name: | CRHF - Micra Transcatheter Pacing System MC1VR01 |
| Model: | Model number - MC1VR01 |
| 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: | The manufacturer has received complaints involving the tether of the Micra Transcatheter Pacing System (TPS) becoming stuck upon tether retrieval. If resistance during tether removal is noted, this could result in the inability to remove the tether from the Micra Implantable Pulse Generator (IPG) and the acute dislodgement of the Micra IPG due to the increased force necessary for tether removal. The removal of the tether from the delivery system is a crucial step during implantation of the IPG. This stuck tether issue can potentially result in prolonged and possibly additional procedures, increasing harm to the patient. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Healthcare Professional |
| Date Commenced: | 31/7/2019 |
