Microvention, Inc. recalls MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating, Ref GW0721006M, 1 guidewire per package, steril…

Recall date

August 7, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3103-2017

FDA classification

Class II

Brand / firm

Microvention, Inc.

Sold / distributed

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.

Why it was recalled

There is a potential for the hydrophilic coating on the guidewire to delaminate from the guidewire.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating, Ref GW0721006M, 1 guidewire per package, sterile, RX.