Class II — Microvention, Inc.
| Recalling firm | MicroVention Inc. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | There is a potential for the hydrophilic coating on the guidewire to delaminate from the guidewire. |
| Product | MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating, Ref GW0721006M, 1 guidewire per package, sterile, RX. |
| 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. |
| Initiated | 2017-08-07 |
| Classified | 2017-09-01 |
| Terminated | 2018-10-26 |
| Recall number | Z-3103-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Microvention, Inc. (Z-3103-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77880/
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