Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System Recalled by Cordis US Corp Due to Potential for stent dislodgement and associated failures related...

Date: May 20, 2022
Company: Cordis US Corp
Status: Ongoing
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 US Corp directly.

Affected Products

PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990BPS, PG2990BPX, PG3990BPS, PG3990BPX.

Quantity: 1,089 units

Why Was This Recalled?

Potential for stent dislodgement and associated failures related to two specific sizes of the device.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Cordis US Corp

Cordis US Corp has 22 total recalls tracked by RecallDetector.

Related Recalls

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