ReFlow Medical recalls Wingman 35 Crossing Catheter, 65cm, Model Numbers: WGM35065US WGM35065CE WGM35090US WGM35090CE WGM35135US WGM35135CE

Recall date

March 22, 2017

Source

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

Recall number

Z-1898-2017

FDA classification

Class I

Brand / firm

ReFlow Medical

Sold / distributed

Worldwide Distribution - US Nationwide in the states of : NJ, FL, CA, GA, MI, OH and countries of: Germany, Turkey, and AU.

Why it was recalled

ReFlow Medical is recalling the Wingman 35 Crossing Catheter because it may be prone to tip detachment.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Wingman 35 Crossing Catheter, 65cm, Model Numbers: WGM35065US WGM35065CE WGM35090US WGM35090CE WGM35135US WGM35135CE