MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating — Class II medical device recall Z-3103-2017
Terminated recall by Microvention, Inc., reported 2017-09-13, distributed in AZ, CA, CO, MA, MI, MN, MO, NY…. There is a potential for the hydrophilic coating on the guidewire to delaminate from the guidewire.
| Recall number | Z-3103-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Microvention, Inc., Tustin, CA, United States |
| Recall initiated | 2017-08-07 |
| Classified | 2017-09-01 |
| Reported by FDA | 2017-09-13 |
| Terminated | 2018-10-26 |
| Distributed | AZ, CA, CO, MA, MI, MN, MO, NY, OH, UT, VA, WI |
| Quantity | 34 units |
| Lot numbers | 17030521, 17032821, 17041831 |
| Model numbers | GW0721006M |
Product
MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating, Ref GW0721006M, 1 guidewire per package, sterile, RX.
Reason for recall
There is a potential for the hydrophilic coating on the guidewire to delaminate from the guidewire.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3103-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.