Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 27545 |
| Brand Name: | CRHF - CareLink SmartSync Device Manager System |
| Model: | Percepta™ CRT-P MRI SureScan™, Percepta™ Quad CRT-P MRI SureScan and Serena™ CRT-P MRI SureScan™, Serena™ Quad CRT-P MRI SureScan |
| 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 identified a software issue with the Medtronic CareLink SmartSync Device Manager (SmartSync) that causes it to incorrectly inflate the battery longevity estimates for Percepta, Serena, and Solara Cardiac Resynchronization Therapy pacemaker (CRT-P) devices (referred to as the CRT-P Quad family of devices). This issue manifests in the period immediately preceding the device Recommended Replacement Time (RRT) when the device is in the pre-RRT state. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Healthcare Professional |
| Date Commenced: | 6/4/2021 |
