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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00545-1
Product Name/Description	MGuard Prime Coronary Stent System Embolic Protective Stent (EPS) Multiple catalogue numbers affected Supplied under the Special Access Scheme (SAS)
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	20/05/2014
Responsible Entity	Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Reason/Issue	The manufacturer, InspireMD, has initiated this recall action due to recent complaints of MGuard Prime EPS dislodgements. These complaints have primarily occurred during the preparation of the MGuard Prime EPS, upon removal of the protective sleeve, or during withdrawal of the MGuard Prime EPS into the guide catheter during the procedure. These complaints have not resulted in any patient injury.
Recall Action	Recall
Recall Action Instructions	Upon getting appropriate regulatory approval, InspireMD intends to perform a manufacturing enhancement to all unexpired units of the MGuard Prime EPS systems to improve stent retention and product performance.
Contact Information	02 9006 1662 - Emergo Australia