Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 28468 |
| Brand Name: | CRHF - CareLink SmartSync Device Manager System |
| Model: | CareLink SmartSync™ Device Manager application software D00U005 |
| 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 that the SmartSync interrogation sessions, or CareLink network transmissions may fail for Cobalt or Crome devices when the current session diagnostic data includes any VT/VF episode type with multiple therapy sequences and three or more data recording suspensions. For these specific episodes, the software is unable to decode and process the data. SmartSync will display a message indicating an Unexpected error occurred, and the application software requires restarting. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 22/10/2021 |
