Saluda Medical warns of charging problems with Evoke Closed Loop Stimulator
The Dutch inspectorate has published a manufacturer field safety notice on unintended stimulation during charging, or failure to charge, with the Evoke CLS.
The Dutch healthcare and youth inspectorate, IGJ, has published a manufacturer warning from Saluda Medical Pty Ltd concerning the Evoke Closed Loop Stimulator (CLS). The company says it has received reports of unintended stimulation while the device is charging, and of the CLS being unable to charge when the charger is applied.
The field safety notice (FSN) is dated 14 October 2026. The IGJ listing carries the date 10 November 2026 and links to a four-page English-language PDF. The notice names MedR-AR Services B.V. as Saluda Medical's authorised representative.
The IGJ page does not set out in its text the number of reports, the devices or lots affected, the cause, or the corrective actions the manufacturer is asking users to take. Those details would be in the linked PDF, which should be consulted directly.
As general context, manufacturers of medical devices must monitor their products after they reach the market and act where a risk to users emerges. They inform users and the competent authorities of such action through a field safety notice.
What it means for your team
- Healthcare providers using the Evoke CLS should read the full FSN for the required actions, as the IGJ summary does not list them.
- Distributors and authorised representatives should check whether the notice has been passed on to affected customers.
- Vigilance and quality teams should record the charging-related reports of unintended stimulation and charging failure in their post-market surveillance files.
Article written by VigiEye from the official source (IGJ). AI-assisted; check the source before acting.
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