Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-01319-1
Product Name/Description	Alligator Retrieval Device, Xcelerator Hydrophilic Guidewire and Marathon Microcatheter (with Stylet) Multiple Catalogue and Lot numbers Manufactured between August 2014 and September 2016 ARTG Numbers: 190843, 203671, 274595
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	7/10/2016
Responsible Entity	Covidien Pty Ltd
Reason/Issue	Medtronic has identified the potential for an issue with a specific set of lot numbers of Medtronic Neurovascular products where the PTFE (polytetrafluoroethylene) coating could de-laminate and separate from the delivery wire. De-lamination and detachment of the PTFE coating material may lead to PTFE coating in the blood stream. PTFE in the blood stream, based on its specific size and quantity could lead to thromboembolic complications or irreversible injuries including but not limited to: intracranial oedema, peripheral oedema, incomplete treatment, infection, local inflammatory response, systemic inflammatory response, ischemic stroke, lysis/necrosis, neurological deficit, organ impairment, shock, space occupying lesion, thrombosis, and haemorrhage. Through September 27 2016, Medtronic has received a total of five (5) reports for the products that are potentially affected by this issue however; no reports of serious injuries or patient death have been reported.
Recall Action	Recall
Recall Action Instructions	Customers are advised to quarantine and remove all unused affected products in their inventory. Medtronic will be issuing a credit for the returned, unused and unexpired device(s). If replacement product is needed, Medtronic representative can assist customers with identifying suitable replacement products. For affected product that has been used, no action is necessary and patients should continue to be managed in accordance with your standard patient management protocol. This action has been closed out on the 10/10/2018.
Contact Information	02 9429 4325 - Medtronic