| TGA Action ID |
RC-2026-RN-00789-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Evoke Closed Loop Stimulator (CLS)
Distribution Dates: From 15 June 2026 onwards
Product Code: 1042 |
| ARTG Number |
508085 |
| Unique Device Identifier (UDI) |
09352307001282 |
| Action Type |
Product Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Saluda Medical has received reports of unintended stimulation during charging or impedance testing, or the inability for the CLS to charge when the charger is applied. This impacts Evoke Closed Loop Stimulators (CLSs) distributed from 15 June 2026 onwards.
The primary risks identified for this problem are temporary unintended stimulation, interruption of therapy, and potential loss of therapy due to battery depletion. This may subsequently lead to device explant or replacement.
As of 6 October 2026, Saluda has received 26 complaints globally from patients related to this problem. None of the reportable events were in Australia. |
| Instructions for Customers/Users |
Saluda confirms that there are no remaining affected product on customer's shelves.
Saluda is not recommending prophylactic replacement or explantation of implanted devices that may be within the affected population. Based on currently available information, greater than 97% of potentially affected devices are expected to continue to perform as intended. Physicians should continue routine patient management and communicate with patients as they deem clinically appropriate.
Customers are to monitor patient's symptoms per the below. If they match, contact a Saluda representative.
- Patient reports unintended stimulation when they try to charge the device AND
- Patient reports unintended stimulation when they start stimulation AND
- Patient reports unintended stimulation during an impedance check.
OR
- Patient reports their device won't charge.?This is confirmed with multiple chargers, and confirmed that CLS is implanted at correct depth and orientation and is not flipped.
The Instructions for Use can be found at https://manuals.saludamedical.com/. |
| Action Commencement Date |
19/10/2026 |
| Responsible Entity |
|
| Contact Information |
02 8405 8700 - Saluda Medical |