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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00012-1
Product Name/Description	Maquet demonstration unit fiber-optic Intra-Aortic Balloon Catheter ARTG Number: N/A Demonstration model only
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	9/01/2015
Responsible Entity	Maquet Australia Pty Ltd
Reason/Issue	During manufacturing of the sterile, for patient-use, SENSATION and SENSATION PLUS IABC products, the Ferrule Cap is intended to be removed from the fiber-optic connection at the time of final packaging. Maquet have identified that during the packaging of some demonstration, fiber-optic SENSATION and SENSATION PLUS IABC units, the Ferrule Cap was not removed. If the fiber-optic connector on an affected non-sterile, non-patient use, demonstration unit is inserted into patient-use MAQUET CS300, CARDIOSAVE Intra-Aortic Balloon Pump (IABP) or IABPs upgraded with a fiber-optic module, the cap may become dislodged and remain in the fiber-optic receptacle of the pump. If a pump unit is subsequently used with a clincal use fiber optic balloon catheter Inserted Into the mating connector, the catheter will notmake an electrical connection with the IABP. The catheter will not be recognised as a fiber optic catheter. The system will still be able to pump as a non fiber optic balloon.
Recall Action	Recall for Product Correction
Recall Action Instructions	Maquet is providing instructions for the inspection of the demonstration units and the Intra-Aortic Balloon Pumps. End users are requested to inspect and remove the Ferrule caps if present on the pump of demonstration catheter. A Maquet technician will inspect potentially affected devices if required. This action has been closed-out on 11/08/2016.
Contact Information	1800 605 824 - Maquet Customer Service