FDA Device recall Z-3103-2017
MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating, Ref GW0721006M, 1 guidewire per package, sterile, RX
- FDA Device
- Class II
- terminated
- Published 2017-09-13
On 2017-09-13 the FDA classified a Class II recall of MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating, Ref GW0721006M, 1 guidewire per package, sterile, RX by Microvention, citing there is a potential for the hydrophilic coating on the guidewire to delaminate from the guidewire.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3103-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-08-07 |
| Published | 2017-09-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Microvention |
| Distribution | AZ, CA, CO, MA, MI, MN, MO, NY, OH, UT, VA, WI |
Product
MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating, Ref GW0721006M, 1 guidewire per package, sterile, RX.
Reason
There is a potential for the hydrophilic coating on the guidewire to delaminate from the guidewire.
Identifiers
| code_info | Lot numbers 17030521, 17032821, and 17041831 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3103-2017%22
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