Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 26084 |
| Brand Name: | CRHF - CareLink SmartSync Device Manager System |
| Model: | Azure™ pacemakers, and Percepta™, Serena™, Solara™ CRT-pacemakers |
| 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: | This update addresses a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e., battery measurements, Capture Management™, Atrial Lead Position Check™, EffectivCRT™ algorithms, and AdaptivCRT™). This rare interaction results in temporary suspension of automatic threshold testing and output adjustments, and suspension of auto-optimisation of CRT therapy. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Healthcare Professional |
| Date Commenced: | 3/6/2020 |
