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Type of Product	Medical Device
TGA Recall Reference	RC-2024-RN-00030-1
Product Name/Description	Optima Coil System Multiple model and lot numbers ARTG 302253 (Getz Healthcare Pty Ltd - Optima Coil System - Neurovascular embolization coil)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	12/01/2024
Responsible Entity	Getz Healthcare Pty Ltd
Reason/Issue	Discoloration along the delivery system pusher component of the Optima Coil System has been identified. The discoloration was observed on the outside of the PET jacket along the hypotube component. The discoloured area may lead to an allergic reaction, foreign emboli, pyrogenic response, adverse response to device materials, chemical aseptic meningitis or difficulty or excessive forces in advancing or retracting the delivery pusher. The affected subassembly product lots were manufactured between July 8, 2020, and March 8, 2021.
Recall Action	Recall
Recall Action Instructions	Customers are to stop using and quarantine any affected stock immediately to prevent further use. Getz Healthcare will arrange the collection of the affected devices.
Contact Information	02 9413 6209 - Getz Quality/Regulatory Department