FDA Device

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

Hazard

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

What You Should Do

Remedy

Letters dated 8/7/2017 were issued on 8/7/2017 via overnight mail to the direct account medical facilities.

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Products

MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating, Ref GW0721006M, 1 guidewire per package, sterile, RX.
Brand
Microvention, Inc.
UPC
Lot numbers 17030521, 17032821, and 17041831

Units Affected

34 units

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