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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00415-1
Product Name/Description	Pipeline Embolization Device and Alligator Retrieval Device Pipeline Embolization Device Product Code: FA-77350-14V07 Lot Number: 9855265 ARTG Number: 186413 Alligator Retrieval Device Product Code: FA-88810-30V03 Lot Number: 9791385 ARTG Number: 190843
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	4/04/2014
Responsible Entity	Covidien Pty Ltd
Reason/Issue	Through internal testing, Covidien identified certain lots of the Pipeline Embolization Device and the Alligator Retrieval Device that have the potential for the PTFE (polytetrafluoroethylene) coating on the delivery wire to delaminate and detach. There have been no patient injuries reported.
Recall Action	Recall
Recall Action Instructions	Covidien is requesting hospitals to discontinue use of the devices and segregate from other inventory. Covidien will arrange for the pick-up and return of the affected devices. This action has been closed-out on 10/02/2016.
Contact Information	1800 350 702 - Covidien Technical Services Team