FDA Medical Device Recalls (openFDA)
Microvention, Inc.: MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating, Ref GW0721006M, 1 guidewire per package, sterile, RX.
- Recall number
- Z-3103-2017
- Recalling firm
- Microvention, Inc.
- Product
- MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating, Ref GW0721006M, 1 guidewire per package, sterile, RX.
- Status
- Terminated
- Initiated
- 2017-08-07
- Posted
- not on file
- Terminated
- 2018-10-26
- 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.
- Lot, serial or model codes
- Lot numbers 17030521, 17032821, and 17041831
- 510(k) numbers
- ["K161803"]
- PMA numbers
- not on file
- Product code
- MOF
- Firm FEI
- 3003523199
- Firm city
- Tustin
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28