Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 35429 |
| Brand Name: | CRHF - CareLink SmartSync Device Manager System |
| Model: | Multiple Software Components |
| Affected: | Update SmartSync (to version 4.2.3 or higher |
| 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: | A software update for Medtronic CareLink™ SmartSync™ Device Manager (SmartSync) is now available. The SmartSync update aligns the Abort button behavior within the EP Study screen with legacy Medtronic programmers. Once the update is applied, the Abort button cancels any therapy in progress initiated via the EP Study screen. In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 19/6/2025 |
