Recall Z-0309-2017 ยท KRA Catheter, Continuous Flush
Micro Therapeutics Inc, Dba Ev3 Neurovascular
Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective inf
| 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 | 66,429 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.