Saluda Medical hits record low after Evoke neurostimulator recall
Saluda Medical shares fell to a record low after the company announced a voluntary recall of some Evoke neurostimulators over a manufacturing issue.
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what happened
Saluda Medical said it is voluntarily recalling certain Evoke neurostimulation devices after finding a problem linked to its manufacturing process. The company said a process change at a third-party manufacturer caused unintended stimulation during charging, or left an implanted device unable to charge.
Saluda reported 26 complaints among roughly 3,900 potentially affected implanted devices. The manufacturing process has since been corrected, and affected non-implanted inventory is being removed and replaced. The company is also working with the US Food and Drug Administration and other regulators, and will notify physicians.
The firm does not expect the recall to disrupt supply or materially affect operations, or push costs beyond its existing earnings and gross margin forecasts. Shares of the Australia-listed company fell to a record low of A$0.275.
why it matters
The story concerns a single small medical device maker, so its reach beyond the stock is limited. For holders of Saluda shares, the key factors are the scale of the recall and any regulatory response, which the company currently expects to be contained.
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- Saluda Medical's shares hit record low on Evoke device recall — Reuters, 21 October 2026 at 00:58 UTC
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