Terumo Medical Corporation recalls Portico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19, PRTSOLO-20

Recall date

April 26, 2019

Source

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

Recall number

Z-1376-2019

FDA classification

Class I

Brand / firm

Terumo Medical Corporation

Sold / distributed

The products were distributed US nationwide. The products were distributed to the following foreign countries: Australia, Belgium, Brazil, Canada, Portugal, Hong Kong, Peru, Singapore.

Why it was recalled

There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting in a loss of the smooth transition from the surface of the tip to the outer surface of the expandable sheath.

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

Portico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19, PRTSOLO-20