Home / Recalls / Medical Devices
Microvention, Inc. recalls MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating, Ref GW0721006M, 1 guidewire per package, sterile
Recalled September 13, 2017 · FDA recall Z-3103-2017 · Microvention
Hazard
There is a potential for the hydrophilic coating on the guidewire to delaminate from the guidewire. · FDA Class II
Units
34 units
Sold at
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.
Description
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.
Manufacturer(s)
Microvention, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →