Key Highlights

  • Saluda Medical, Inc (ASX:SLD) shares trading at $0.27 on 21 October 2026, down 19.40%.
  • Saluda announced a voluntary field action for a defined population of Evoke Closed Loop Stimulators.
  • The company reported 26 complaints among approximately 3,900 potentially affected implanted devices, a rate of about 0.66%, and is not recommending prophylactic replacement.

Saluda Medical, Inc (ASX:SLD) shares fell 19.40% to trade at $0.27 during the trading session on 21 October 2026, while the S&P/ASX 200 (XJO) stood at 8,809.20, down 7.70 points or 0.087%. On the same day, Saluda released an ASX announcement on a voluntary field action involving certain Evoke System devices.

About Saluda Medical

Saluda Medical, Inc. is a commercial-stage medical device company focused on treatments for chronic neurological conditions using its neuromodulation platform. Its closed-loop platform senses neural responses to stimulation and adjusts therapy automatically. The Evoke System is indicated as an aid in managing chronic intractable pain of the trunk and limbs.

What the field action covers

Saluda said it is initiating a voluntary field action involving a defined population of Evoke Closed Loop Stimulators after identifying a low-incidence issue related to a third-party manufacturing process change. The manufacturing process has been corrected, and devices manufactured and distributed after the corrective action are not included in the affected population.

The issue was found to result in temporary unintended stimulation associated with charging, or an inability to charge the implanted device.

Complaint rate and patient guidance

Based on the latest information, 26 complaints have been reported among approximately 3,900 potentially affected implanted devices, a reported complaint rate of about 0.66% accumulated over more than two years. Saluda’s statistical projections indicate the expected future risk is approximately 29 additional complaints over the remaining life of the devices.

Saluda is not recommending prophylactic replacement or explantation, and is advising physicians to continue routine patient management. Where a device cannot be charged, the physician may decide that replacement or another intervention is appropriate. Patients who have not experienced the issue do not need to take action.

Inventory actions and financial effect

As part of the action, Saluda is notifying physicians and providers with potentially affected shelf inventory, removing and replacing affected non-implanted inventory by serial number, and developing a screening process for non-implanted inventory made before the corrective action. The company is also engaging with the U.S. Food and Drug Administration and other regulators about the action and its classification.

Saluda does not expect disruption to product supply or its ability to meet demand, does not currently expect a material effect on operations, and estimates costs will fit within its adjusted EBITDA and gross margin percentage guidance ranges.

Sector context

Medical device makers are subject to post-market surveillance requirements, and field actions are a recognised mechanism for addressing identified issues in marketed products. Regulators such as the U.S. FDA review and classify these actions.

Implanted neuromodulation devices are used over long periods, so complaint rates are usually tracked across the devices’ service lives.

Risks and uncertainties

Saluda said regulatory engagement is ongoing, and the classification of the action has not been determined. Complaint numbers could change as more information becomes available, and the projection of about 29 additional complaints is a statistical estimate.

Costs, product supply and the effect on operations are described as expected outcomes based on current information, and they may differ if the scope of the action changes. Patients with devices that cannot be charged may require intervention.

What's next

Saluda said it is developing a screening process for non-implanted inventory made before the corrective action and continues to engage with the FDA and other authorities. Further developments on the classification of the field action may be reported to the market.