Image credit: Saluda Medical
Saluda Medical has initiated a voluntary field action after a manufacturing-process change at a supplier was linked to unintended stimulation and charging failures in certain Evoke closed-loop spinal cord stimulators. According to Reuters’ October 21 report, the company identified approximately 3,900 potentially affected implanted devices and said the manufacturing process had been corrected. Affected unimplanted inventory is being removed and replaced.
Australia’s Therapeutic Goods Administration lists a Class II product alert covering Evoke CLS product code 1042 distributed from June 15, 2026. Its notice describes unintended stimulation during charging or impedance testing, and devices that cannot recharge. Battery depletion could interrupt therapy and ultimately require replacement. Saluda had received 26 complaints worldwide by October 6. The notice states that the company is not recommending preventive explantation or replacement of potentially affected implants.