Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-01369-1
Product Name/Description	Bard Inlay Optima Ureteral Stents InLay Optima Multi-length Ureteral Stent with NiCoreNitinol/Nitinol Guidewire Product Codes: 786400, 786600, 786700, 786800 InLay Optima Multi-length Ureteral Stent with HydroGlide Guidewire Product Codes: 787400, 787600, 787700, 787800 InLay Optima Multi-length Ureteral Stent without Guidewire Product Codes: 788400, 788600, 788700, 788800 ARTG Number: 235658
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	18/10/2016
Responsible Entity	Bard Australia Pty Ltd
Reason/Issue	The Food and Drug Administration (FDA) has requested manufacturers of multi-length ureteral stents to add a statement in the Warnings/Precautions section of product labelling, requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal. Bard has completed an internal assessment and concluded that there is the potential for a moderate severity of harm to a patient should the medical professional fail to consider the formation of a knot if significant resistance is encountered during attempts at removal. Bard is including additional warning/precaution for all of Bard’s multi-length ureteral stents.
Recall Action	Recall for Product Correction
Recall Action Instructions	Bard is including additional warning/precaution for all of Bard’s multi-length ureteral stents: Formation of knots in multi-length ureteral stents may occur. This may result in injury to the ureter during removal and/or the need for additional surgical intervention. The presence of a knot should be considered if significant resistance is encounter during attempts at removal. Users are advised to follow the above warning/precaution for the stock they currently hold. Any stock purchased after November 15, 2016 is expected to have the above warning/precaution statement in the labelling. This action has been closed-out on 18/05/2017.
Contact Information	02 8875 4070 - Bard Australia