Boston Scientific Corporation recalls Imager II 5F Angiographic Catheters, 5 units per package.

Recall date

February 11, 2020

Source

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

Recall number

Z-1555-2020

FDA classification

Class I

Brand / firm

Boston Scientific Corporation

Sold / distributed

Worldwide distribution. US nationwide, Australia, Belgium, Brazil, Canada, Switzerland, China, Colombia, Cyprus, Czech Republic, Germany, Spain, Finland, France, Great Britain, Greece, Croatia, Hungary, Indonesia, Israel, India, Italy, Jordan, Japan, South Korea, Lebanon, Lithuania, Mexico, Malaysi…

Why it was recalled

Potential for tip detachment of Imager II 5F Angiographic Catheters

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

Imager II 5F Angiographic Catheters, 5 units per package.