| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00414-1 |
| Product Name/Description |
CareLink Monitor and CareLink Express Monitor
(used to gather information from an implanted heart device and transmit this information to the individual’s healthcare professional)
Model Numbers: 2020B and 2490C
ARTG Numbers: 116038 and 193374 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/04/2016 |
| Responsible Entity |
|
| Reason/Issue |
A recent software update for selected CareLink/CareLink Express Monitors included an incorrect telephone number. The telephone number is used when the home monitor is transmitting information to the CareLink network. Therefore, monitors that have received this update may no longer be able to transmit information, including CareAlerts, as well as receiving future software updates. The matter does not affect the continued safe operation of an individual’s implant in the immediate term. However if not addressed, a continued inability to connect to the CareLink network may cause premature battery depletion for the implant.
In a worst case scenario, the reported issue may result in early surgery to replace the implant and/or a reduction in the extended service period. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
For affected clinics/patients, Medtronic will arrange for the delivery of a cellular or internet accessory to connect to the patients’ existing monitor to restore the functionality of the affected units. This action has been closed out on 20/01/2017. |
| Contact Information |
1800 644 128 – Medtronic ANZ CareLink Support |