Recall Z-0308-2017 ยท DQY Catheter, Percutaneous
Micro Therapeutics Inc, Dba Ev3 Neurovascular
Alligator Retrieval Device The device is intended for use in the peripheral and neurovasculature for foreign body removal. Catalog No. FA-88810-20V04 FA-88810-20V06 FA-88810-30V04 FA-88810-30V06 FA-88810-40V04 FA-88810-40V06 FA-88810-50V04 FA-88810-50V06
| 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 | 3,337 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.