Abbott Vascular recalls NC Tenku RX PTCA Balloon Catheter, Part No. 1012448-08T, 1012448-12T, 1012448-15T, 1012449-08T, 1012449-12T, 1012449-15…

Recall date

March 22, 2017

Source

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

Recall number

Z-2039-2017

FDA classification

Class I

Brand / firm

Abbott Vascular

Sold / distributed

US and Worldwide

Why it was recalled

Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating the balloon.

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

NC Tenku RX PTCA Balloon Catheter, Part No. 1012448-08T, 1012448-12T, 1012448-15T, 1012449-08T, 1012449-12T, 1012449-15T, 1012450-08T, 1012450-12T, 1012450-15T, 1012451-08T, 1012451-12T, 1012451-15T, 1012452-08T, 1012452-12T, 1012452-15T, 1012453-08T, 1012453-12T