Class II — Potential Health Hazard

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

Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For Recalled by Cordis Corporation Due to Dilatation catheters could exhibit radial versus axial tears...

Date: February 5, 2013
Company: Cordis Corporation
Status: Terminated
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

Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use.

Quantity: 80 units

Why Was This Recalled?

Dilatation catheters could exhibit radial versus axial tears should they burst during inflation.

Where Was This Sold?

This product was distributed to 9 states: AZ, FL, IL, LA, MA, NJ, OR, SC, TX

Affected (9 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