Boston Scientific Corporation recalls Stingray" Guidewire, labeled as 300cm. intended to facilitate placement of balloon dilatation catheters or other intrav…

Recall date

December 19, 2018

Source

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

Recall number

Z-0852-2019

FDA classification

Class II

Brand / firm

Boston Scientific Corporation

Sold / distributed

Nationwide distribution to AR, CT, FL, IA, IL, IN, KY, MA, MI, ND, NJ, NY, OH, OK, PA, SC, TX, VA, WI, WY.

Why it was recalled

A batch of 185cm Stingray Guidewires are incorrectly labeled as 300cm guidewires.

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

What was recalled

Stingray" Guidewire, labeled as 300cm. intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).