Saluda Medical's shares hit record low on Evoke device recall
Saluda Medical's shares hit record low on Evoke device recall Oct 21 (Reuters) - Saluda Medical SLD.AX 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)
((Paridhi.Minda@thomsonreuters.com;))
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