Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 36993 |
| Brand Name: | Affera HexaGEN RF Generators and HexaPulse PF Generators |
| Model: | Model - AFR-00004 |
| Affected: | Affected Software - 1.1.5 and 1.3.1 |
| 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: | As of March 2026, Medtronic has received complaints related to software anomalies. Potential impacts associated with these anomalies include minor procedure delay, and improbable, theoretical risks of collateral tissue injury, transient heart block, or cancelled procedure. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 2/7/2026 |
