Medtronic Vascular Galway DBA Medtronic Ireland recalls Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the fem…

Recall date

May 12, 2020

Source

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

Recall number

Z-2039-2020

FDA classification

Class I

Brand / firm

Medtronic Vascular Galway DBA Medtronic Ireland

Sold / distributed

US distribution in TX, WI, CA, NY, AL, and MI.

Why it was recalled

Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection)

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

Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries.