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Type of Product	Medical Device
TGA Recall Reference	RC-2020-RN-00183-1
Product Name/Description	Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology Product Number/Catalogue Number: PED-250-XX, PED-275-XX, PED-300-XX, PED-325-XX, PED-350-XX, PED-375-XX, PED-400-XX, PED-425-XX, ED-450-XX, PED-475-XX, PED-500-XX, PED2-250-XX, PED2-275-XX, PED2-300-XX, PED2-325-XX, PED2-350-XX, PED2-375-XX, PED2-400-XX, PED2-425-XX, PED2-450-XX, PED2-475-XX, PED2-500-XX All lots manufactured 22-Oct -2019 to 01-Feb-2020 ARTG: 251273, 230661
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	19/02/2020
Responsible Entity	Medtronic Australasia Pty Ltd
Reason/Issue	Medtronic has identified the potential for device fracture at the distal section during use due to a weakened bond in a subset of devices that have been recently manufactured. Use of affected product may result in unintended separation, where the distal portion of the device delivery system remains in the patient. If this occurs, it may result in significant patient injury, including a prolonged procedure, ischemic stroke, intracranial haemorrhage, neurological deficit, and/or death. No complaints related to the issue have been confirmed within the affected population at this time. This is a peri-procedural risk. If a Pipeline Flex embolization device has already been implanted successfully, there is no increased risk to patients due to the issue. Those patients with an implanted device should continue with their normal course of treatment.
Recall Action	Recall
Recall Action Instructions	Medtronic is advising customers to remove and quarantine all unused affected products in their inventory. Users should NOT use any affected product. Affected product should be returned to Medtronic. This action has been closed out on 21/10/2020
Contact Information	08 6389 5608 - Tim Holwell