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Type of Product	Medical Device
TGA Recall Reference	RC-2020-RN-00825-1
Product Name/Description	Pipeline Flex Embolization Device All Product Models Pipeline Flex Embolization Device Catalogue Numbers: PED-250-XX, PED-275-XX, PED-300-XX, PED-325-XX, PED-350-XX, PED-375-XX, PED-400-XX, PED-425-XX, PED-450-XX, PED-475-XX, PED-500-XX Pipeline Flex Embolization Device with Shield Technology Catalogue Numbers: 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 ARTG: 251273, 230661
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	10/09/2020
Responsible Entity	Medtronic Australasia Pty Ltd
Reason/Issue	In February 2020, Medtronic initiated RC-2020-RN-00183-1 based on the increased rate of solder joint failure (16.53%) observed during bench-top testing on Pipeline Flex units built from 22 October 19 to 1 February 2020 compared to the historic rates for solder joint failure (0.07%) and overall pushwire break/separation (0.30%). The risk assessment for potential harm exhibited occurrence rates of separation above the predicted (baseline) risk threshold and therefore, these units potentially posed an increased risk to patient safety. The Instructions for Use (IFU) for the Pipeline Flex embolization device already contains warnings and cautions related to potential of fracture or separation. Medtronic will be supplementing the Instructions for Use with further updates to one of the Precaution and Warning statements and the Device Complications section.
Recall Action	Product Defect Correction
Recall Action Instructions	Customers are advised to be aware of the Information for Use (IFU) updates as described in the Customer Letter (supplied to impacted customers). Medtronic will be supplementing the IFU with further updates to one of the Precaution and Warning statements and the Device Complications section. The updated IFU will be posted on the Medtronic e-Manuals page. Medtronic recommends that physicians be attentive to the updated information in the IFU and include this information in discussions with patients. This action has been closed out on 24/11/2021
Contact Information	0424144137 - Timothy Holwell