Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

PRECISE PRO RX CAROTID STENT implant system Recalled by Cordis Corporation Due to Distal tip may become separated from the lumen...

Date: February 11, 2021
Company: Cordis Corporation
Status: Completed
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Cordis Corporation directly.

Affected Products

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

Quantity: 18218 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 2 states: MT, NM

Affected (2 states)Not affected

About Cordis Corporation

Cordis Corporation has 39 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report