Recall Z-0307-2017 ยท OUT Intracranial Aneurysm Flow Diverter
Micro Therapeutics Inc, Dba Ev3 Neurovascular
Pipeline Embolization Device (Pipeline Classic) The device is indicated for the endovascular treatment of adults (22 year of age or older) with large or giant widenecked intracranial aneurysms (lAs) in the internal carotid artery from the petrous to the superior hypophyseal segements. Catalog No. FA-71300-25V09 FA-71350-25V16 FA-71400-25V10 FA-71425-35V13 FA-71475-30V16 FA-71300-25V12 FA-7
| Date | Nov 9, 2016 (initiated Oct 5, 2016) |
| Status | Terminated |
| Reason | Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream. |
| Root cause | Device Design |
| Action | Medtronic sent an Urgent Medical Device Recall letter dated October 5, 2016, to all affected customers to inform them that Medtronic has identified the potential for an issue with a specific set of lot numbers of Medtronic Neurovascular products as noted where the PTFE (polytetrafluoroethylene) coating could delaminate and separate from the delivery wire. Customers are instructed to complete the attached customer confirmation certificate and fax it to Medtronic at (949) 434-5020 to the attention of Neurovascular Quality. On October 14, 2016, Medtronic announced that it has notified customers |
| Quantity | 11,860 units |
| Distribution | Worldwide Distribution - US (nationwide) and Internationally to Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Hong Kong |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.