FDA recall Z-1257-2021

Cordis Corporation · Class I · device

Product

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

Reason for recall

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

Distribution

US (except MT and NM) and Taiwan

Key facts

Status: Completed
Initiation date: 2021-02-11
Report date: 2021-03-24
Voluntary/Mandated: Voluntary: Firm initiated
Location: Miami Lakes, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1257-2021