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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00440-1
Product Name/Description	Pulsar-35 and Pulsar-18 and peripheral self-expanding Nitinol stent systems (with stent length of 200 mm only) Pulsar-35 Product Codes: 379921, 379941, 379926, 379946, 379931, 379951 Specific Lots ARTG number: 169368 Pulsar-18 Product Codes: 366812, 366832, 366817, 366837, 366822, 366842, 366827, 366847 Specific Lots ARTG number: 142025
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	25/05/2015
Responsible Entity	Biotronik Australia Pty Ltd
Reason/Issue	Biotronik has received a higher than expected number of complaints regarding incomplete stent deployments with specific sizes and lots of our Pulsar-18 and Pulsar-35 peripheral self-expanding Nitinol stent systems. Potential health hazards resulting from this type of failure include increased procedure time, vessel wall injury or the need to remove the incompletely deployed stent. Stents that have already been implanted are not affected as the issue occurs during deployment of the stent.
Recall Action	Recall
Recall Action Instructions	Users are advised to discontinue any further use of the affected stock and remove them from their inventory. A sales representative will contact customers to collect the affected stock. This action has been closed-out on 02/12/2016.
Contact Information	1800 227 346 - BIOTRONIK Australia Pty Ltd