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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-01446-1
Product Name/Description	Cordis S.M.A.R.T. Flex Vascular Stent System Multiple Lot Numbers and SKU Codes ARTG Number: 223910
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	29/11/2017
Responsible Entity	Cardinal Health Australia 503 Pty Ltd
Reason/Issue	Cordis has determined that certain lots of the S.M.A.R.T. Flex Vascular Stent system have a potential for cracked luer hubs, due to a manufacturing error. The luer hub is used to inject contrast/saline during procedure preparation, prior to insertion of the stent system into the patient. A cracked hub could result in leakage of saline, or in the worst case, inability to flush the outer sheath of the catheter. The potential medical consequence would be a delay in device preparation, resulting in the need to prepare a replacement device for use. Cordis does not anticipate any other patient impact.
Recall Action	Recall
Recall Action Instructions	Cordis is advising users to inspect stock and quarantine any remaining units of the affected product for return. This action has been closed out on 17/10/2018
Contact Information	02 8935 9419 - Cordis Health