Saluda Medical recalls some Evoke spinal cord stimulators over a charging problem
A manufacturing change at a supplier can cause unintended stimulation during charging or leave an implant unable to charge. Saluda reports 26 complaints among about 3,900 implanted devices that may be affected.
Saluda Medical announced a voluntary recall of certain Evoke Closed Loop Stimulators on October 21, Reuters reported. A process change at a third-party manufacturer can cause unintended stimulation during charging or leave an implanted device unable to charge. The company counts 26 complaints among about 3,900 potentially affected implants. Its shares fell to a record low of A$0.275.
Saluda says the process has been corrected, unimplanted stock is being replaced, and a screening process is being developed for devices made before the fix. It is talking with the FDA and other regulators and expects no supply disruption. Reuters did not report any injuries, and Kalkine Media said no FDA risk classification had been published yet.
Learn more: Spinal cord stimulation · Saluda Medical