Cordis Corporation recalls PRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC0530RXC, PC0540RXC, PC0620RXC, PC0630RXC, PC06…

Recall date

February 11, 2021

Source

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

Recall number

Z-1257-2021

FDA classification

Class I

Brand / firm

Cordis Corporation

Sold / distributed

US (except MT and NM) and Taiwan

Why it was recalled

Distal tip may become separated from the lumen wire in specific lots.

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

PRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC0530RXC, PC0540RXC, PC0620RXC, PC0630RXC, PC0640RXC, PC0720RXC, PC0730RXC, PC0740RXC, PC0820RXC, PC0830RXC, PC0840RXC, PC0920RXC, PC0930RXC, PC0940RXC, PC1030RXC, PC1040RXC