Oct 21 (Reuters) – Saluda Medical said on Wednesday it is undertaking a voluntary recall of certain Evoke neurostimulation devices after identifying a manufacturing-related issue, sending shares of the US-based firm to a record low.
Here are the details:
• The recall relates to certain Evoke Closed Loop Stimulators after Saluda identified a low-incidence issue stemming from a third-party manufacturing process change
• The manufacturing change resulted in unintended stimulation during charging or an inability to charge an implanted device, the medical devices firm said
• Saluda said it received 26 complaints out of 3,900 potentially affected implanted devices
• The Minnesota-headquarted company said the relevant manufacturing process has been corrected and it is removing and replacing affected non-implanted inventory
• The company is also engaging with the US Food and Drug Administration and other regulators regarding the recall
• Saluda will also notify physicians and healthcare providers with potentially affected stock and develop a screening process for devices manufactured before the corrective action was implemented
• The company said it does not expect the action to disrupt product supply, materially affect operations or push costs outside its existing operating earnings and gross margin forecasts
• Shares of Australia-listed Saluda fell to a record low of A$0.275
(Reporting by Paridhi Minda; Editing by Sherry Jacob-Phillips)
