Recall Z-3103-2017 ยท MOF Guide, Wire, Catheter, Neurovasculature
Microvention, Inc.
MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating, Ref GW0721006M, 1 guidewire per package, sterile, RX.
| Date | Aug 7, 2017 |
| Status | Terminated |
| Reason | There is a potential for the hydrophilic coating on the guidewire to delaminate from the guidewire. |
| Root cause | Under Investigation by firm |
| Action | Letters dated 8/7/2017 were issued on 8/7/2017 via overnight mail to the direct account medical facilities. |
| Quantity | 34 units |
| Distribution | Distribution was made to medical facilities located in AZ, CA, CO, MA, MI, MN, MO, NY, OH UT, VA, and WI. There was no foreign/military/government distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161803 | Traxcess .007 Mini Guidewire MicroVention, Inc., Sep 30, 2016 |