Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB recalled over entrapment hazard

Recall date

July 21, 2021

Source

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

Official notice title

Cordis Corporation recalls Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter, REF SRD6785MB

Recall number

Z-2428-2021

FDA classification

Class I

Brand / firm

Cordis Corporation

Sold / distributed

Worldwide distribution - US Nationwide distribution and the countries of Canada, Europe.

Why it was recalled

Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a manner that may allow entrapment of the catheter between endovascular devices and the vessel wall, which can lead to marker band movement or dislodgement.

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

Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter, REF SRD6785MB