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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-01391-1
Product Name/Description Eluvia 150mm and Innova 200mm Stent Systems

Multiple Products and Material Numbers

ARTG Numbers: 285061 and 104281
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 7/11/2017
Responsible Entity Boston Scientific Pty Ltd
Reason/Issue Boston Scientific is initiating a removal from the market of the150mm Eluvia Drug-Eluting Vascular Stent System and the 200mm Innova Self-Expanding Stent System due to elevated complaint rates for partial stent deployment.

There have been 190 complaints of partial deployment. Partial deployment occurs when the stent is unable to be fully released from the delivery system. Part of the stent can become anchored in the vessel while the rest of the stent remains within the delivery system. The most common reported injury has been additional medical or minor surgical intervention, vessel trauma or prolongation of the implant procedure. However, Boston Scientific has received reports in 14 cases of major surgery to retrieve the stent/delivery system or to correct vascular compromise.
Recall Action Recall
Recall Action Instructions Boston Scientific is advising users to inspect stock and quarantine the affected products for return for credit.

This action has been closed out on 17/01/2024
Contact Information 1800 676 133 - Boston Scientific Customer Service